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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linagliptin | Experimental | once a day |
|
| placebo | Placebo Comparator | once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linagliptin | Drug | once a day |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at Week 24 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change From Baseline at Week 6 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and at week 6 |
| HbA1c Change From Baseline at Week 12 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. |
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Inclusion criteria:
Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug (antidiabetic therapy has to be unchanged for 6 weeks prior to informed consent and patients should receive standard diet and exercise counseling) A dose of >/=1500 mg/day metformin is required for inclusion into the trial. The dosage needs to be stable for at least 8 weeks before randomisation. Patients with a total daily dose of less than 1500 mg metformin will only be included; if the investigator has documented them to be on their maximum tolerated dose (also in this case the 8 week time interval will apply for a stable dose).
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
Age = 18 and < 80 years at Visit 1a (Screening)
BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation
Exclusion criteria:
Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).
Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with an injectable Glucagon-like peptide- 1 (GLP-1) analogue (e.g. exenatide) , Dipeptidyl-Peptidase 4 (DPP-IV) inhibitor within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent.
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent
Pre-menopausal women (last menstruation =1 year prior to informed consent) who:
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)
Dehydration by clinical judgement of the investigator
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1218.65.86007 Boehringer Ingelheim Investigational Site | Beijing | China | ||||
| 1218.65.86011 Boehringer Ingelheim Investigational Site |
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A total of 614 patients were screened in 19 centres in China, Malaysia,and Philippines.A total of 306 patients were randomised in a 1:2 ratio to receive either placebo (101 patients) or linagliptin 5 mg (205 patients) in addition to metformin.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Linagliptin 5mg | Linagliptin 5mg, once daily tablets, oral |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
once a day |
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| Baseline and at week 12 |
| HbA1c Change From Baseline at Week 18 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and at week 18 |
| HbA1c Change From Baseline at Week 24(Chinese Only) | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | Baseline and at 24 weeks |
| FPG Change From Baseline at Week 24 | Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication. | Baseline and at week 24 |
| FPG Change From Baseline at Week 6 | Means are treatment adjusted for baseline FPG and previous anti-diabetic medication. | Baseline and at week 6 |
| FPG Change From Baseline at Week 12 | Means are treatment adjusted for baseline FPG and previous anti-diabetic medication. | Baseline and at week 12 |
| FPG Change From Baseline at Week 18 | Means are treatment adjusted for baseline FPG and previous anti-diabetic medication. | Baseline and at week 18 |
| Number of Patients With HbA1c < 7.0% | Number of patients with HbA1c < 7.0% at week 24 | baseline and at week 24 |
| Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%. | Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%. | baseline and at week 24 |
| Number of Patients With HbA1c < 6.5% | Number of patients with HbA1c < 6.5% at week 24 | baseline and at week 24 |
| Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%. | Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%. | baseline and at week 24 |
| Number With HbA1c at Least Lowering 0.5% | Number with HbA1c at least 0.5% lowering from baseline at week 24 | baseline and at week 24 |
| Chongqing |
| China |
| 1218.65.86008 Boehringer Ingelheim Investigational Site | Dalian | China |
| 1218.65.86010 Boehringer Ingelheim Investigational Site | Fuzhou | China |
| 1218.65.86014 Boehringer Ingelheim Investigational Site | Hangzhou | China |
| 1218.65.86005 Boehringer Ingelheim Investigational Site | Hefei | China |
| 1218.65.86006 Boehringer Ingelheim Investigational Site | Hefei | China |
| 1218.65.86012 Boehringer Ingelheim Investigational Site | Nanjing | China |
| 1218.65.86001 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1218.65.86002 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1218.65.86003 Boehringer Ingelheim Investigational Site | Shanghai | China |
| 1218.65.86004 Boehringer Ingelheim Investigational Site | Suzhou | China |
| 1218.65.86015 Boehringer Ingelheim Investigational Site | Wenzhou | China |
| 1218.65.86009 Boehringer Ingelheim Investigational Site | Wuhan | China |
| 1218.65.86013 Boehringer Ingelheim Investigational Site | Yangzhou | China |
| 1218.65.60002 Boehringer Ingelheim Investigational Site | Johor Bahru | Malaysia |
| 1218.65.60001 Boehringer Ingelheim Investigational Site | Kelantan | Malaysia |
| 1218.65.63001 Boehringer Ingelheim Investigational Site | Marikina City | Philippines |
| 1218.65.63002 Boehringer Ingelheim Investigational Site | San Juan City | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Linagliptin 5mg | Linagliptin 5mg, once daily tablets, oral |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| BMI | Baseline body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Baseline HbA1c | Baseline HbA1c | Mean | Standard Deviation | % |
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| Baseline fasting plasma glucose | Baseline fasting plasma glucose | Mean | Standard Deviation | mg/dL |
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| 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 | HbA1c Change From Baseline at Week 24 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and at week 24 |
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| Secondary | HbA1c Change From Baseline at Week 6 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and at week 6 |
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| Secondary | HbA1c Change From Baseline at Week 12 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and at week 12 |
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| Secondary | HbA1c Change From Baseline at Week 18 | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and at week 18 |
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| Secondary | HbA1c Change From Baseline at Week 24(Chinese Only) | Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (Chinese only). Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | Percent | Baseline and at 24 weeks |
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| Secondary | FPG Change From Baseline at Week 24 | Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and at week 24 |
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| Secondary | FPG Change From Baseline at Week 6 | Means are treatment adjusted for baseline FPG and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and at week 6 |
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| Secondary | FPG Change From Baseline at Week 12 | Means are treatment adjusted for baseline FPG and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and at week 12 |
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| Secondary | FPG Change From Baseline at Week 18 | Means are treatment adjusted for baseline FPG and previous anti-diabetic medication. | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and at week 18 |
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| Secondary | Number of Patients With HbA1c < 7.0% | Number of patients with HbA1c < 7.0% at week 24 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF). | Posted | Number | Participants | baseline and at week 24 |
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| Secondary | Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%. | Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%. | This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF). | Posted | Number | Participants | baseline and at week 24 |
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| Secondary | Number of Patients With HbA1c < 6.5% | Number of patients with HbA1c < 6.5% at week 24 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF). | Posted | Number | Participants | baseline and at week 24 |
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| Secondary | Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%. | Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%. | This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF). | Posted | Number | Participants | baseline and at week 24 |
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| Secondary | Number With HbA1c at Least Lowering 0.5% | Number with HbA1c at least 0.5% lowering from baseline at week 24 | The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF). | Posted | Number | Participants | baseline and at week 24 |
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24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 2 | 100 | 13 | 100 | ||
| EG001 | Linagliptin 5mg | Linagliptin 5mg, once daily tablets, oral | 4 | 205 | 29 | 205 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Lacunar infarction | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| 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 |
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| ID | Term |
|---|---|
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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