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
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: 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 July 20, 2014