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Completed

NCT Number: NCT01511172

Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Daw Park, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
  • Duration of type 2 diabetes diagnosis at least one year
  • HbA1c 8.0-13.0%, both inclusive
  • Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive.

Exclusion criteria

  • Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
  • Impaired liver function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
  • Recurrent major 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 glucose level
  • Known or suspected abuse of alcohol or narcotics
  • Any contraindications to metformin or glimepiride according to the local guidelines

Treatment and study plan

liraglutide

Drug

Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously

metformin

Drug

1000 mg daily, administered orally

Placebo

Drug

Metformin placebo administered orally. 1000 mg daily

Glimepiride

Drug

Individually adjusted dose, administered orally

Primary outcomes

  1. Fasting plasma/serum glucose

Secondary outcomes

  1. Home monitored fasting plasma glucose

  2. Home monitored 7-point glucose profile

  3. Fructosamine

  4. Insulin

  5. C-peptide

  6. HbA1c (glycated haemoglobin A1c)

  7. Weight

  8. Beta-cell function and insulin resistance (HOMA model)

  9. Gastro-intestinal adverse events

  10. Other adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Jan 18, 2012
Registry last updated
Jan 25, 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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