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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01562561
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: insulin NPH Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 1, 2001
Actual Primary Completion Date : December 20, 2002
Actual Study Completion Date : December 20, 2002

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rep + NPH Drug: repaglinide
2 mg at each main meal

Drug: insulin NPH
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.
Active Comparator: NPH Drug: insulin NPH
Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0 (visit 5); week 26 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
  • BMI (body mass index) maximum 35 kg/m^2
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562561


Locations
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Hong Kong
Novo Nordisk Investigational Site
Shatin, New Territories, Hong Kong
Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Philippines
Novo Nordisk Investigational Site
Marikina City, Philippines, 1800
Novo Nordisk Investigational Site
Pasig City, Philippines, 1605
Novo Nordisk Investigational Site
Quezon City, Philippines, 1100
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Brits, North West, South Africa, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7460
Novo Nordisk Investigational Site
Alberton, South Africa, 1449
Taiwan
Novo Nordisk Investigational Site
Tainan city, Taiwan, 710
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562561    
Other Study ID Numbers: AGEE-1272
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
 Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs