Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin. |
|---|---|
| Condition | Diabetes Diabetes Mellitus, Type 2 |
| Intervention | Drug: liraglutide Drug: insulin glargine Drug: metformin Drug: glimepiride |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Responsible Party | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier | NCT00331851 |
| First Received | May 30, 2006 |
| Last Updated | December 11, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 30, 2006 |
|---|---|
| Last Updated Date | December 11, 2013 |
| Start Date | May 2006 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | HbA1c [Time Frame: after 26 weeks of treatment] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes |
|---|---|
| Official Title | Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm. |
| Brief Summary | This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin. |
| 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 |
|
| Intervention | Drug: liraglutide Drug: insulin glargine Drug: metformin Drug: glimepiride |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 584 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | April 2007 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Treatment with oral anti-diabetic drugs for at least 3 months - HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy. - Body Mass Index (BMI) less than or equal to 45 kg/m2 Exclusion Criteria: - Treatment with insulin within the last 3 months - Treatment with any drug that could interfere with the glucose level - Any serious medical condition - Females who are pregnant, have intention of becoming pregnant or are breastfeeding |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Argentina, Austria, Denmark, Finland, Former Serbia and Montenegro, France, India, Italy, Netherlands, Norway, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00331851 |
|---|---|
| Other Study ID Numbers | NN2211-1697 |
| Has Data Monitoring Committee | No |
| Information Provided By | Novo Nordisk A/S |
| Study Sponsor | Novo Nordisk A/S |
| Collaborators | Not Provided |
| Investigators | Study Director: Milan Zdravkovic, MD, Ph.D Novo Nordisk A/S |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| Argentina | Mendoza, Argentina, 5500 |
|---|---|
| Austria | Wien, Austria, 1030 |
| Denmark | Århus C, Denmark, 8000 |
| Finland | Kuopio, Finland, 70210 |
| Former Serbia and Montenegro | Belgrade, Former Serbia and Montenegro, 11000 |
| France | LA ROCHELLE cedex, France, 17019 |
| India | Patna, India, 800020 |
| Italy | Bologna, Italy, 40133 |
| Netherlands | Den Haag, Netherlands, 2512 VA |
| Norway | Gjettum, Norway, 1346 |
| Philippines | Marikina City, Philippines, 1810 |
| Poland | Katowice, Poland, 40-053 |
| Russian Federation | Moscow, Russian Federation, 123448 |
| Slovakia | L'ubochna, Slovakia, 03491 |
| South Africa, Gauteng | Pretoria, Gauteng, South Africa, 0001 |
| Spain | Getafe, Spain, 28905 |
| United Kingdom | Guildford, United Kingdom, GU2 7XX |