Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00614120

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: placebo Drug: glimepiride Drug: metformin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride Liraglutide Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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).

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.

Enrollment:	929
Study Start Date:	January 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lira 0.6 + Met Liraglutide 0.6 mg + metformin + glimepiride placebo	Drug: liraglutide 0.6 mg/day, s.c. (under the skin) injection Drug: placebo Glimepiride placebo, capsules Drug: metformin Tablets, 1.5-2.0 g/day
Experimental: Lira 1.2 + Met Liraglutide 1.2 mg + metformin + glimepiride placebo	Drug: placebo Glimepiride placebo, capsules Drug: liraglutide 1.2 mg/day, s.c. (under the skin) injection Drug: metformin Tablets, 1.5-2.0 g/day
Experimental: Lira 1.8 + Met Liraglutide + metformin + glimepiride placebo	Drug: placebo Glimepiride placebo, capsules Drug: liraglutide 1.8 mg/day, s.c. (under the skin) injection Drug: metformin Tablets, 1.5-2.0 g/day
Experimental: Glim + Met Glimepiride 4.0 mg + metformin + liraglutide placebo	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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Body Mass Index (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614120

Locations

China, Beijing

Beijing, Beijing, China, 100029
India

Hyderabad, A.P, India, 500 001
Korea, Republic of

Sungnam, Gyeongi-do, Korea, Republic of, 463-707

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Marcin Zychma, MD, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. Epub 2011 Mar 30.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00614120 History of Changes
Other Study ID Numbers:	NN2211-1796
Study First Received:	January 15, 2008
Results First Received:	February 23, 2010
Last Updated:	April 16, 2010
Health Authority:	China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA); India: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012