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OpenTrials
Completed

NCT Number: NCT01509755

Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.

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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

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes
  • Duration of diabetes at least 3 months
  • Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)
  • Body Mass Index maximum 40 kg/m^2
  • HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated

Exclusion criteria

  • Liver or renal disease
  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Proliferative retinopathy
  • Recurrent severe hypoglycaemia 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 Investigator's opinion could interfere with the blood glucose level

Treatment and study plan

Placebo

Drug

Once daily injection, under the skin (s.c.) for 12 weeks

liraglutide

Drug

Once daily injection, under the skin (s.c.) for 12 weeks

Other names: NNC 90-1170

Glimepiride

Drug

Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response

Primary outcomes

  1. HbA1c (glycosylated haemoglobin)

Secondary outcomes

  1. Fasting plasma glucose

  2. Fructosamine

  3. 7-point blood glucose profile

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Jan 13, 2012
Registry last updated
Jan 24, 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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