Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes | RxWiki

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
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
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	Change in Body Weight [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in body weight from baseline (week 0) to 16 weeks (end of treatment) Change in Self-measured Fasting Plasma Glucose [Time Frame: week 0, week 16] [Designated as safety issue: No]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. 7-point Self-measured Plasma Glucose Profiles [Time Frame: week 0, 8, 12 and 16] [Designated as safety issue: No]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). Change in Beta-cell Function [Time Frame: week 0, week 16] [Designated as safety issue: No]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). Change in Fasting Lipid Profile [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on: Total Cholesterol (TC) Low-density Lipoprotein-cholesterol (LDL-C) Very Low-density Lipoprotein-cholesterol (VLDL-C) High-density Lipoprotein-cholesterol (HDL-C) Triglyceride (TG) Free Fatty Acid (FFA) Change in Fasting Lipid Profile, APO-B [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment). Hypoglycaemic Episodes [Time Frame: weeks 0-16] [Designated as safety issue: Yes]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.

Descriptive Information[ + expand ][ + ]

Brief Title	Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
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	Diabetes Diabetes Mellitus, Type 2
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)	Experimental: Lira 0.6 + Met Liraglutide 0.6 mg + metformin + glimepiride placebo Experimental: Lira 1.2 + Met Liraglutide 1.2 mg + metformin + glimepiride placebo Experimental: Lira 1.8 + Met Liraglutide + metformin + glimepiride placebo Experimental: Glim + Met Glimepiride 4.0 mg + metformin + liraglutide placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
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
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

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