| April 25, 2006 |
| October 13, 2009 |
| May 2006 |
| November 2008 (final data collection date for primary outcome measure) |
| HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ] |
| HbA1c after 26 weeks of treatment. |
| Complete list of historical versions of study NCT00318461 on ClinicalTrials.gov Archive Site |
- Body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Glycaemic control parameters (fasting plasma glucose, 7-point glucose profiles) [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Beta-cell function [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: Yes ]
|
- Glycemic control parameters (fasting plasma glucose, -glucose profiles)
- body weight
- The 26 weeks double-blind period will be followed by an 18 months open label extension.
- Βeta-cell function
- Safety and tolerability.
|
| |
| To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together |
| Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes |
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride.
The 26 weeks double-blind period will be followed by an 18 months open label extension. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Diabetes Mellitus, Type 2 |
- Drug: liraglutide
- Drug: metformin
- Drug: glimepiride
- Drug: placebo
|
| |
- Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15.
- Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12.
- Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, Düring M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. Epub 2008 Oct 17.
|
| |
| Completed |
| 1091 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least 3 months
- HbA1c: 7.0-11.0 % (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 40 kg/m2
Exclusion Criteria:
- Subjects treated with insulin within the last three months
- Subjects with any serious medical condition
- Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
- Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
|
| Both |
| 18 Years to 80 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Belgium, Bulgaria, Croatia, Denmark, Germany, Hungary, India, Ireland, Italy, Netherlands, New Zealand, Norway, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, United Kingdom |
| |
| NCT00318461 |
| Public Access to Clinical Trials, Novo Nordisk A/S |
| NN2211-1572 |
| Novo Nordisk |
|
| Study Director: |
Martin Lange |
Novo Nordisk |
|
|
| Novo Nordisk |
| October 2009 |