Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562561
First received: March 22, 2012
Last updated: December 19, 2016
Last verified: December 2016
  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) [ Time Frame: Week 0 (visit 5); week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG (fasting plasma glucose) [ Time Frame: Week 0 (visit 5); week 26 ] [ Designated as safety issue: No ]
  • 7-point blood glucose profile [ Time Frame: Week 0 (visit 5); week 26 ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: Week 0 (visit 5); week 26 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Week 0 (Visit 5); week 26 ] [ 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   (Adult, Senior)
Genders 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
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
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
Study Director: Per Knud Christensen Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: 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: December 19, 2016
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
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 17, 2017