Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00568074
• Collaborator: (none)
• Enrollment: 131
• Locations: 4
• Duration (Months): 8.6
• Patients Per Site: 32.8
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects being treatment-naive type 2 diabetics.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: repaglinide; Drug: Glurenorm®; Drug: Glucobay®	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus
• Study Start Date: Dec 16, 2003
• Actual Primary Completion Date: Sep 2, 2004
• Actual Study Completion Date: Sep 2, 2004

Outcome Measures

Primary Outcome Measures

1. HbA1c [after 3 months of treatment]

Secondary Outcome Measures

1. fasting blood glucose []

2. hypoglycaemia episodes []

3. adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetes

• No previous treatment for diabetes

• HbA1c: 7.0-12.0%

Exclusion Criteria:

• Type 1 diabetes

• Uncontrolled treated/untreated hypertension

• Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results

• Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures (adequate contraceptive measures are: sterilisation, intra-uterine device (IUD), oral contraceptives or barrier methods)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200025
2	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200433
3	Novo Nordisk Investigational Site	Chengdu	Sichuan	China	610041
4	Novo Nordisk Investigational Site	Beijing		China	100029

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00568074
• Other Study ID Numbers: AGEE-1555
• First Posted: Dec 5, 2007
• Last Update Posted: Feb 20, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Repaglinide; Acarbose; Gliquidone

Study Results

No Results Posted as of Feb 20, 2017