Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002276-16 | EudraCT Number | EudraCT |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linagliptin + metformin | Experimental | patients to receive linagliptin +metformin QD |
|
| metformin | Active Comparator | patients to receive metformin BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin placebo | Drug | metformin placebo tablets 500mg |
| |
| linagliptin placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment | Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c. | Baseline and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment) |
Not provided
Inclusion criteria:
Exclusion criteria:
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day);
Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris),stroke or Transient ischemia attack (TIA) within 3 months prior to informed consent;
Indication of liver disease/Impaired hepatic function, defined by serum levels of either Aspartate aminotransferase (ALT or SGPT), alanine aminotransferase (AST or SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at visit 1 and/or run-in phase,
Impaired renal function, defined as eGFR< 60ml/min (moderate or severe renal impairment, modification of diet in renal disease (MDRD) formula) as determined during screening or at run-in phase
Bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption
Medical history of Cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Blood dyscrasia or any other disorders causing haemolysis or unstable Red Blood Cell (eg. malaria, babesiosis, haemolytic anemia)
Known history of pancreatitis and chronic pancreatitis
Contraindications to metformin according to the local label
Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM
Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
Participation in another trial with application of any investigational drug within 30 days prior to informed consent
Any other clinical condition that would jeopardize patients safety while participating in this trial
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.60.90001 Boehringer Ingelheim Investigational Site | Dhaka | Bangladesh | ||||
| 1218.60.90002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25805187 | Derived | Ji L, Zinman B, Patel S, Ji J, Bailes Z, Thiemann S, Seck T. Efficacy and safety of linagliptin co-administered with low-dose metformin once daily versus high-dose metformin twice daily in treatment-naive patients with type 2 diabetes: a double-blind randomized trial. Adv Ther. 2015 Mar;32(3):201-15. doi: 10.1007/s12325-015-0195-3. Epub 2015 Mar 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lina 5mg + Met qd | Patients treated with Linagliptin 5mg in combination with metformin once daily. |
| FG001 | Met Bid | Patients treated with metformin alone twice daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| Drug |
linagliptin placebo tablets 5mg |
|
| metformin | Drug | metformin tablets 500mg |
|
| metformin | Drug | metformin tablets 500 mg |
|
| linagliptin | Drug | linagliptin tablets 5mg |
|
| 14 weeks |
| Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment | Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks | 14 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment | Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose. | Baseline and 14 weeks |
| Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment | Patients could experience multiple events, therefore, multiple answers were possible for each patient. | 14 weeks |
| Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment | The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c. | 14 weeks |
| Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment). | 14 weeks |
| Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) | The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment). | 14 weeks |
| Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) | The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment). | 14 weeks |
| Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment). | 14 weeks |
| Change From Baseline in Body Weight by Visit at Week 14 | Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight | Baseline and 14 weeks |
| Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment). | 14 weeks |
| Change From Baseline in HbA1c Over Time | Means are adjusted by treatment and continuous baseline HbA1c | Baseline, 2 weeks and 8 weeks |
| Dhaka |
| Bangladesh |
| 1218.60.90003 Boehringer Ingelheim Investigational Site | Dhaka | Bangladesh |
| 1218.60.32001 Boehringer Ingelheim Investigational Site | Genk | Belgium |
| 1218.60.32005 Boehringer Ingelheim Investigational Site | Ham | Belgium |
| 1218.60.32002 Boehringer Ingelheim Investigational Site | Hasselt | Belgium |
| 1218.60.32004 Boehringer Ingelheim Investigational Site | Natoye | Belgium |
| 1218.60.32003 Boehringer Ingelheim Investigational Site | Tremelo | Belgium |
| 1218.60.20009 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada |
| 1218.60.20003 Boehringer Ingelheim Investigational Site | Burnaby | British Columbia | Canada |
| 1218.60.20014 Boehringer Ingelheim Investigational Site | Coquitlam | British Columbia | Canada |
| 1218.60.20010 Boehringer Ingelheim Investigational Site | Surrey | British Columbia | Canada |
| 1218.60.20004 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia | Canada |
| 1218.60.20012 Boehringer Ingelheim Investigational Site | Corunna | Ontario | Canada |
| 1218.60.20015 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1218.60.20006 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1218.60.20013 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1218.60.20002 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1218.60.20011 Boehringer Ingelheim Investigational Site | Sarnia | Ontario | Canada |
| 1218.60.20005 Boehringer Ingelheim Investigational Site | Strathroy | Ontario | Canada |
| 1218.60.20007 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1218.60.20016 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1218.60.20001 Boehringer Ingelheim Investigational Site | Saint Romuald | Quebec | Canada |
| 1218.60.86001 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1218.60.86003 Boehringer Ingelheim Investigational Site | Beijing | China |
| 1218.60.86011 Boehringer Ingelheim Investigational Site | Changsha | China |
| 1218.60.86012 Boehringer Ingelheim Investigational Site | Chengdu | China |
| 1218.60.86010 Boehringer Ingelheim Investigational Site | Chongqing | China |
| 1218.60.86013 Boehringer Ingelheim Investigational Site | Hubei | China |
| 1218.60.86014 Boehringer Ingelheim Investigational Site | Hubei | China |
| 1218.60.86006 Boehringer Ingelheim Investigational Site | Nanjing | China |
| 1218.60.86007 Boehringer Ingelheim Investigational Site | Nanjing | China |
| 1218.60.86005 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1218.60.86009 Boehringer Ingelheim Investigational Site | Shenyang | China |
| 1218.60.86008 Boehringer Ingelheim Investigational Site | Wuxi | China |
| 1218.60.49007 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1218.60.49008 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1218.60.49005 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1218.60.49004 Boehringer Ingelheim Investigational Site | Erfurt | Germany |
| 1218.60.49006 Boehringer Ingelheim Investigational Site | Frankfurt | Germany |
| 1218.60.49003 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1218.60.49002 Boehringer Ingelheim Investigational Site | Neuwied | Germany |
| 1218.60.49001 Boehringer Ingelheim Investigational Site | Unterschneidheim | Germany |
| 1218.60.50001 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 1218.60.50002 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 1218.60.50003 Boehringer Ingelheim Investigational Site | Guatemala City | Guatemala |
| 1218.60.85001 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong |
| 1218.60.85002 Boehringer Ingelheim Investigational Site | Hong Kong | Hong Kong |
| 1218.60.91004 Boehringer Ingelheim Investigational Site | Aurangabad | India |
| 1218.60.91010 Boehringer Ingelheim Investigational Site | Bangalore | India |
| 1218.60.91005 Boehringer Ingelheim Investigational Site | Coimbatore | India |
| 1218.60.91008 Boehringer Ingelheim Investigational Site | Kolkata | India |
| 1218.60.91001 Boehringer Ingelheim Investigational Site | Nagpur | India |
| 1218.60.91007 Boehringer Ingelheim Investigational Site | Nagpur | India |
| 1218.60.91003 Boehringer Ingelheim Investigational Site | Pune | India |
| 1218.60.91006 Boehringer Ingelheim Investigational Site | Pune | India |
| 1218.60.96001 Boehringer Ingelheim Investigational Site | Beirut | Lebanon |
| 1218.60.96002 Boehringer Ingelheim Investigational Site | Beirut | Lebanon |
| 1218.60.96004 Boehringer Ingelheim Investigational Site | Byblos | Lebanon |
| 1218.60.96003 Boehringer Ingelheim Investigational Site | Hazmiyeh | Lebanon |
| 1218.60.96005 Boehringer Ingelheim Investigational Site | Saida | Lebanon |
| 1218.60.52005 Boehringer Ingelheim Investigational Site | Aguascalientes | Mexico |
| 1218.60.52003 Boehringer Ingelheim Investigational Site | Cuernavaca | Mexico |
| 1218.60.52001 Boehringer Ingelheim Investigational Site | Durango | Mexico |
| 1218.60.52002 Boehringer Ingelheim Investigational Site | Durango | Mexico |
| 1218.60.52004 Boehringer Ingelheim Investigational Site | Monterrey | Mexico |
| 1218.60.51001 Boehringer Ingelheim Investigational Site | Lima | Peru |
| 1218.60.51002 Boehringer Ingelheim Investigational Site | Lima | Peru |
| 1218.60.51004 Boehringer Ingelheim Investigational Site | Piura | Peru |
| 1218.60.63001 Boehringer Ingelheim Investigational Site | Cebu City, Philippines | Philippines |
| 1218.60.63004 Boehringer Ingelheim Investigational Site | Iloilo City, Philippines | Philippines |
| 1218.60.63003 Boehringer Ingelheim Investigational Site | Manila | Philippines |
| 1218.60.63002 Boehringer Ingelheim Investigational Site | Marikina City, Philippines | Philippines |
| 1218.60.63005 Boehringer Ingelheim Investigational Site | Quezon City | Philippines |
| 1218.60.34001 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1218.60.34002 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1218.60.34003 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1218.60.34004 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1218.60.34006 Boehringer Ingelheim Investigational Site | Borges Del Camp- Tarragona | Spain |
| 1218.60.34005 Boehringer Ingelheim Investigational Site | Centelles | Spain |
| 1218.60.34009 Boehringer Ingelheim Investigational Site | Granada | Spain |
| 1218.60.34008 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | Spain |
| 1218.60.34007 Boehringer Ingelheim Investigational Site | Mataró | Spain |
| 1218.60.34010 Boehringer Ingelheim Investigational Site | Valencia | Spain |
| 1218.60.88006 Boehringer Ingelheim Investigational Site | Chiayi County | Taiwan |
| 1218.60.88003 Boehringer Ingelheim Investigational Site | Kaohsiung City | Taiwan |
| 1218.60.88001 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1218.60.88007 Boehringer Ingelheim Investigational Site | Taichung | Taiwan |
| 1218.60.88002 Boehringer Ingelheim Investigational Site | Tainan | Taiwan |
| 1218.60.88004 Boehringer Ingelheim Investigational Site | Taipei County | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set (TS): all patients treated with at least 1 dose of randomised study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lina 5mg + Met qd | Patients treated with Linagliptin 5mg in combination with metformin once daily. |
| BG001 | Met Bid | Patients treated with metformin alone twice daily. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment | Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c. | FAS1000mg with last observation carried forward (LOCF): all patients randomised and treated who had a baseline at least 1 on-treatment HbA1c value and who tolerated a daily metformin dose of at least 1000 mg at the end of the titration phase. | Posted | Mean | Standard Error | percent | Baseline and 14 weeks |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment) | Patients from FAS1000 with non-completer considered as failure (NCF) having a baseline HbA1c>=7.0%. | Posted | Number | participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment | Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks | Patients from FAS1000 | Posted | Number | participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment | Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose. | Patients from FAS1000 with LOCF | Posted | Mean | Standard Error | mg/dL | Baseline and 14 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment | Patients could experience multiple events, therefore, multiple answers were possible for each patient. | Patients from FAS1000 and having GI adverse events which were assessed for severity by the investigator. | Posted | Number | events | 14 weeks | Events | Participants |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment | The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c. | Patients from the FAS1000 using original results (OR) and having GI adverse events which were assessed for severity by the patient. | Posted | Mean | Standard Error | units on a scale | 14 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment). | Patients from FAS1000 (NCF) having a baseline HbA1c>=6.5%. | Posted | Number | participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) | The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment). | Patients from FAS1000 (NCF) | Posted | Number | participants | 14 weeks |
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| Secondary | Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) | The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment). | Patients from the FAS1000 (NCF) | Posted | Number | participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment). | Patients from FAS1000 (NCF) | Posted | Number | participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight by Visit at Week 14 | Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight | FAS1000 having values for weight at baseline and week 14. | Posted | Mean | Standard Error | kg | Baseline and 14 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks | The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment). | Patients from FAS1000 (NCF) | Posted | Number | participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HbA1c Over Time | Means are adjusted by treatment and continuous baseline HbA1c | Patients from FAS1000 (LOCF) | Posted | Mean | Standard Error | percent | Baseline, 2 weeks and 8 weeks |
|
|
14 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lina 5mg + Met qd | Patients treated with Linagliptin 5mg in combination with metformin once daily. | 2 | 344 | 101 | 344 | ||
| EG001 | Met Bid | Patients treated with metformin alone twice daily. | 7 | 345 | 121 | 345 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MEDDRA 15.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 15.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Vocal cord leukoplakia | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 15.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
Not provided
Not provided
| Male |
|
| 0.8924 |
| Mean Difference (Final Values) |
| -0.01 |
| Standard Error of the Mean |
| 0.06 |
| 95 |
| -0.13 |
| 0.12 |
| No |
| Superiority or Other |
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