Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: liraglutide Drug: placebo Drug: liraglutide Drug: liraglutide Drug: glimepiride Drug: metformin Drug: placebo |
Phase | Phase 3 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00614120 |
First Received | January 15, 2008 |
Last Updated | June 19, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | January 15, 2008 |
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Last Updated Date | June 19, 2012 |
Start Date | January 2008 |
Estimated Primary Completion Date | February 2009 |
Current Primary Outcome Measures | Change in Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: week 0, week 16] [Designated as safety issue: No]Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment). |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes |
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Official Title | Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes |
Brief Summary | 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 |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition |
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Intervention | Drug: liraglutide 0.6 mg/day, s.c. (under the skin) injection Drug: placebo Glimepiride placebo, capsules Drug: liraglutide 1.2 mg/day, s.c. (under the skin) injection Drug: liraglutide 1.8 mg/day, s.c. (under the skin) injection Drug: glimepiride Capsules, 4.0 mg/day Drug: metformin Tablets, 1.5-2.0 g/day Drug: placebo Liraglutide placebo, s.c. (under the skin) injection |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 929 |
Estimated Completion Date | February 2009 |
Estimated Primary Completion Date | February 2009 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months - HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone - HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy - BMI less than 45.0 kg/m2 Exclusion Criteria: - Treatment with insulin within the last 3 months prior to the trial - Impaired liver or/and renal function - Significant cardiovascular disease over the last 6 months - Known retinopathy or maculopathy - Recurrent major hypoglycaemia or hypoglycaemic unawareness |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China, India, Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00614120 |
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Other Study ID Numbers | NN2211-1796 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Marcin Zychma, MD, PhD Novo Nordisk A/S |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
China, Beijing | Beijing, Beijing, China, 100029 |
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India | Hyderabad, India, 500 001 |
Korea, Republic of | Sungnam, Korea, Republic of, 463-707 |