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OpenTrials
Completed

NCT Number: NCT01562561

Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Shatin, New Territories, Hong Kong

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
  • BMI (body mass index) maximum 35 kg/m^2

Treatment and study plan

repaglinide

Drug

2 mg at each main meal

insulin NPH

Drug

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Primary outcomes

  1. HbA1c (glycosylated haemoglobin)

    Time frame: Week 0 (visit 5); week 26

Secondary outcomes

  1. FPG (fasting plasma glucose)

    Time frame: Week 0 (visit 5); week 26

  2. 7-point blood glucose profile

    Time frame: Week 0 (visit 5); week 26

  3. Hypoglycaemic episodes

    Time frame: Week 0 (visit 5); week 26

  4. Adverse events

    Time frame: Week 0 (Visit 5); week 26

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Mar 26, 2012
Registry last updated
Feb 20, 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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