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
Overview[ - collapse ][ - ]
Purpose | 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. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks). |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: liraglutide Drug: metformin Drug: glimepiride Drug: placebo Drug: placebo Drug: liraglutide Drug: liraglutide |
Phase | Phase 3 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00318461 |
First Received | April 25, 2006 |
Last Updated | November 25, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | April 25, 2006 |
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Last Updated Date | November 25, 2013 |
Start Date | May 2006 |
Estimated Primary Completion Date | November 2008 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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Official Title | 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 |
Brief Summary | 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. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks). |
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 for s.c. (under the skin) injection. Drug: metformin 1.5-2.0 g tablets Drug: glimepiride 4 mg tablets Drug: placebo Glimepiride placebo 1 mg and 2 mg tablets Drug: placebo Liraglutide placebo 1-3 mL for s.c. (under the skin) injection Drug: liraglutide 1.2 mg for s.c. (under the skin) injection Drug: liraglutide 1.8 mg for 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 | 1091 |
Estimated Completion Date | November 2008 |
Estimated Primary Completion Date | May 2007 |
Eligibility Criteria | Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) 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) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | 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 |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00318461 |
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Other Study ID Numbers | NN2211-1572 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Martin Lange Novo Nordisk A/S |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Argentina | Ciudad Autonoma de Bs As, Argentina, C1405CWB |
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Australia | Box Hill, Australia, 3128 |
Belgium | Gent, Belgium, 9000 |
Bulgaria | Sofia, Bulgaria, 1431 |
Croatia | Zagreb, Croatia, 10 000 |
Denmark | Herlev, Denmark, 2730 |
Germany | Bad Lauterberg, Germany, 37431 |
Hungary | Pecs, Hungary, 7631 |
India | Bangalore, India, 560034 |
Ireland | Dublin, Ireland, DUBLIN 7 |
Italy | Milano, Italy, 20132 |
Netherlands | Groningen, Netherlands, 9728 NT |
New Zealand | Auckland, New Zealand |
Norway | Hamar, Norway, 2317 |
Romania | Constanta, Romania, 900591 |
Russian Federation | Moscow, Russian Federation, 123448 |
Slovakia | Kosice, Slovakia, 04-001 |
South Africa, Gauteng | Johannesburg, Gauteng, South Africa, 27 11 |
Spain | Málaga, Spain, 29010 |
Sweden | Stockholm, Sweden, 171 76 |
United Kingdom | East Horsley, United Kingdom, KT24 6QT |