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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562561
First received: March 22, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG (fasting plasma glucose) [ Designated as safety issue: No ]
  • 7-point blood glucose profile [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: June 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562561

Locations
Hong Kong
Hong Kong, Hong Kong
Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Philippines
Pasig City, Philippines, 1605
South Africa
Pretoria, Gauteng, South Africa
Taiwan
Tainan, Taiwan, 710
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Per Knud Christensen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562561     History of Changes
Other Study ID Numbers: AGEE-1272
Study First Received: March 22, 2012
Last Updated: March 23, 2012
Health Authority: Hong Kong: Department of Health
Malaysia: Medical Research Ethics Committee
Philippines: Bureau of Food and Drugs
South Africa: Medicines Control Council
Taiwan: Department of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Repaglinide
Insulin
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014