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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01720303
First received: October 31, 2012
Last updated: February 17, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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

Secondary Outcome Measures:
  • Change in FBG (Fasting Blood Glucose)
  • Change in body weight

Enrollment: 159
Actual Study Start Date: September 19, 2002
Study Completion Date: April 10, 2003
Primary Completion Date: April 10, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100101
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200040
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: 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: February 17, 2017

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

ClinicalTrials.gov processed this record on April 21, 2017