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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01720303
First received: October 31, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide
Drug: isophane human insulin
Drug: insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in HbA1c [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in FBG (Fasting Blood Glucose) [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: September 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rep + NPH Drug: repaglinide
2 mg (tablets) before each main meal
Drug: isophane human insulin
Injection s.c. (under the skin) at bedtime
Active Comparator: Premixed insulin/NPH Drug: insulin
Injection s.c. (under the skin) twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c between 7.5 % and 13.0% (both inclusive)
  • Fasting C-peptide above or equal to 0.33 nmol/l
  • BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion Criteria:

  • Medical history of treatment with insulin within the last 6 months
  • Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720303

Locations
China, Shanghai
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Qian Hongyu Novo Nordisk (China) Pharmaceuticals Co., Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01720303     History of Changes
Other Study ID Numbers: AGEE-3020
Study First Received: October 31, 2012
Last Updated: October 31, 2012
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on April 21, 2014