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Completed

NCT Number: NCT01511198

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

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Vestavia Hills, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Injected subcutaneously once daily

Other names: NNC 90-1170

metformin

Drug

1000 mg twice daily, administered orally

Primary outcomes

  1. Body weight

Secondary outcomes

  1. FPG (fasting plasma glucose)

  2. HbA1c (glycosylated haemoglobin)

  3. Fructosamine

  4. Lipids

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jan 18, 2012
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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