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This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lira 0.6 + Met | Experimental | Liraglutide 0.6 mg + metformin + glimepiride placebo |
|
| Lira 1.2 + Met | Experimental | Liraglutide 1.2 mg + metformin + glimepiride placebo |
|
| Lira 1.8 + Met | Experimental | Liraglutide + metformin + glimepiride placebo |
|
| Glim + Met | Experimental | Glimepiride 4.0 mg + metformin + liraglutide placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | 0.6 mg/day, s.c. (under the skin) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) | Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment). | week 0, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight from baseline (week 0) to 16 weeks (end of treatment) | week 0, week 16 |
| Change in Self-measured Fasting Plasma Glucose | Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452), MD, PhD | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100029 | China | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21114607 | Result | Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, Bhattacharyya A, Kumar A, Kim KW, Yoon KH, Bech OM, Zychma M. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.x. | |
| 23010561 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
A metformin run-in period of 3 weeks followed by a metformin maintenance period of 3 weeks before randomisation with dose levels increased to 2000 mg/day. Subjects already on metformin therapy at enrolment could go through a modified titration period or advance directly to the metformin maintenance period at the discretion of the investigator.
A total of 51 centres in three countries: China (17), India (24) and South Korea (10)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lira 0.6 + Met | Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo |
| FG001 | Lira 1.2 + Met | Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
Glimepiride placebo, capsules |
|
| liraglutide | Drug | 1.2 mg/day, s.c. (under the skin) injection |
|
| liraglutide | Drug | 1.8 mg/day, s.c. (under the skin) injection |
|
| glimepiride | Drug | Capsules, 4.0 mg/day |
|
| metformin | Drug | Tablets, 1.5-2.0 g/day |
|
| placebo | Drug | Liraglutide placebo, s.c. (under the skin) injection |
|
| week 0, week 16 |
| 7-point Self-measured Plasma Glucose Profiles | Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16). | week 0, 8, 12 and 16 |
| Change in Beta-cell Function | Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5). | week 0, week 16 |
| Change in Fasting Lipid Profile | Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:
| week 0, week 16 |
| Change in Fasting Lipid Profile, APO-B | Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment). | week 0, week 16 |
| Hypoglycaemic Episodes | Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | weeks 0-16 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Novo Nordisk Investigational Site | Chongqing | Chongqing Municipality | 400010 | China |
| Novo Nordisk Investigational Site | Fuzhou | Fujian | 350025 | China |
| Novo Nordisk Investigational Site | Harbin | Heilongjiang | 150001 | China |
| Novo Nordisk Investigational Site | Harbin | Heilongjiang | 150086 | China |
| Novo Nordisk Investigational Site | Wuhan | Hubei | 430022 | China |
| Novo Nordisk Investigational Site | Nanjing | Jiangsu | 210008 | China |
| Novo Nordisk Investigational Site | Suzhou | Jiangsu | 215004 | China |
| Novo Nordisk Investigational Site | Wuxi | Jiangsu | 214023 | China |
| Novo Nordisk Investigational Site | Xi'an | Shaanxi | 710032 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200003 | China |
| Novo Nordisk Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| Novo Nordisk Investigational Site | Shenyang | 110001 | China |
| Novo Nordisk Investigational Site | Tianjin | 300052 | China |
| Novo Nordisk Investigational Site | Wuhan | 430060 | China |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500 001 | India |
| Novo Nordisk Investigational Site | Hyderbad | Andhra Pradesh | 500 012 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380 015 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560 017 | India |
| Novo Nordisk Investigational Site | Kochi | Kerala | 695010 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400010 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411 037 | India |
| Novo Nordisk Investigational Site | New Dehli | New Delhi | 110029 | India |
| Novo Nordisk Investigational Site | Bhubaneswar | Odisha | 751019 | India |
| Novo Nordisk Investigational Site | Jaipur | Rajasthan | 302006 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600 013 | India |
| Novo Nordisk Investigational Site | Madurai | Tamil Nadu | 625 020 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700054 | India |
| Novo Nordisk Investigational Site | Ghaziabad | India |
| Novo Nordisk Investigational Site | Kochi | 682 304 | India |
| Novo Nordisk Investigational Site | Kolkata | 700017 | India |
| Novo Nordisk Investigational Site | Kolkata | 700026 | India |
| Novo Nordisk Investigational Site | Mumbai | 400 0067 | India |
| Novo Nordisk Investigational Site | Mumbai | 400016 | India |
| Novo Nordisk Investigational Site | New Delhi | 110017 | India |
| Novo Nordisk Investigational Site | Patna | 800020 | India |
| Novo Nordisk Investigational Site | Secunderabad | 500 003 | India |
| Novo Nordisk Investigational Site | Trivandrum | 695029 | India |
| Novo Nordisk Investigational Site | Visakhapatnam | 530002 | India |
| Novo Nordisk Investigational Site | Goyang | 410-719 | South Korea |
| Novo Nordisk Investigational Site | Incheon | 405-220 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 03080 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 08308 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 130-872 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 135-710 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 137-701 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 150-713 | South Korea |
| Novo Nordisk Investigational Site | Sungnam | 463-707 | South Korea |
| Novo Nordisk Investigational Site | Suwon | 16499 | South Korea |
| Result |
| Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23. |
| 25504028 | Result | Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. |
| 25684604 | Result | Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19. |
| 21450987 | Derived | Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30. |
| FG002 | Lira 1.8 + Met | Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo |
| FG003 | Glim + Met | Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo |
| Exposed to Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lira 0.6 + Met | Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo |
| BG001 | Lira 1.2 + Met | Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo |
| BG002 | Lira 1.8 + Met | Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo |
| BG003 | Glim + Met | Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo |
| BG004 | 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 |
| ||||||||||||||||
| Previous OAD treatment | OAD = Oral Anti-Diabetic Drug | Number | participants |
| |||||||||||||||
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m2 |
| ||||||||||||||
| Duration of diabetes | Number of years since diagnosis | Mean | Standard Deviation | years |
| ||||||||||||||
| Height | Mean | Standard Deviation | m |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 in Glycosylated Haemoglobin A1c (HbA1c) | Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment). | The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Mean | Standard Deviation | percentage point of total HbA1c | week 0, week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight | Change in body weight from baseline (week 0) to 16 weeks (end of treatment) | The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Mean | Standard Deviation | kg | week 0, week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Self-measured Fasting Plasma Glucose | Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary. | The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Mean | Standard Deviation | mg/dL | week 0, week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 7-point Self-measured Plasma Glucose Profiles | Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16). | The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Mean | Standard Deviation | mg/dl | week 0, 8, 12 and 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Beta-cell Function | Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5). | The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Mean | Standard Deviation | percentage point (%point) | week 0, week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Lipid Profile | Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:
| The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Mean | Standard Deviation | mmol/L | week 0, week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Lipid Profile, APO-B | Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment). | The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products. | Posted | Median | Standard Deviation | g/L | week 0, week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycaemic Episodes | Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products. | Posted | Number | episodes | weeks 0-16 |
|
The adverse events were collected over a time span of 16 weeks.
The safety analysis set is all who had been exposed to at least one dose of the study products.
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 | Lira 0.6 + Met | Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo | 4 | 231 | 67 | 231 | ||
| EG001 | Lira 1.2 + Met | Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo | 8 | 233 | 98 | 233 | ||
| EG002 | Lira 1.8 + Met | Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo | 4 | 233 | 113 | 233 | ||
| EG003 | Glim + Met | Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo | 4 | 231 | 30 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Adams-Stokes syndrome | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebellar haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cubital tunnel syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cryptogenic cirrhosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication and other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Combination therapy |
|
The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level. |
| Non-Inferiority or Equivalence |
Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%. |
| Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c. Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%. | ANCOVA | ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate. | <.0001 | In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide. | Estimated treatment difference, LS Mean | 0.03 | 95 | -0.14 | 0.20 | The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level. | Non-Inferiority or Equivalence | Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%. |
| Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c. Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%. | ANCOVA | ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate. | 0.0421 | In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide. | Estimated treatment difference, LS Mean | 0.25 | 95 | 0.08 | 0.42 | The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. | Non-Inferiority or Equivalence | Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%. |
| Units | Counts |
|---|
| Participants |
|
|
|
|
Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
|
|
| Glim + Met |
Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo |
|
|
Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo |
|
|