Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

Phase 2

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide; Drug: metformin

• Registration Number: NCT01511198
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

• Type 2 diabetic
• Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
• Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)
• HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria

• Cardiac problems
• Uncontrolled treated/untreated hypertension
• Proliferative retinopathy or known autonomic neuropathy
• Recurrent severe hypoglycemia as judged by the investigator
• Known or suspected allergy to trial product or related products
• Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
• Known or suspected abuse of alcohol or narcotics
• Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
• TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
• Type 1 or other specific causes of diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.045 mg	liraglutide	-
0.225 mg	liraglutide	-
0.45 mg	liraglutide	-
0.60 mg	liraglutide	-
0.75 mg	liraglutide	-
Met	metformin	-

Primary Outcome Measures

Name	Time	Method
Body weight

Secondary Outcome Measures

Name	Time	Method
FPG (fasting plasma glucose)
HbA1c (glycosylated haemoglobin)
Adverse events
Fructosamine
Lipids

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Charleston, West Virginia, United States