Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00568984
• Date of registration: 04/12/2007
• Primary sponsor: Novo Nordisk
• Public title: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
• Scientific title: Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus
• Date of first enrolment: November 2002
• Target sample size: 324
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00568984
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China, Malaysia, Philippines, Thailand

Contacts

• Name: Jing Ping Yeo
• Affiliation: Novo Nordisk Asia Pacific Pte.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 2 diabetes for at least 3 months

- No previous treatment for diabetes

- HbA1c between 7.0-12.0%

- Body Mass Index (BMI) between 19.0-40.0 kg/m2

Exclusion Criteria:

- Type 1 diabetes

- Known unstable/untreated proliferative retinopathy

- Uncontrolled treated/untreated hypertension

- Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using
inadequate contraceptive measures



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: glicazide

Drug: metformin

Drug: repaglinide

Primary Outcome(s)

HbA1c [Time Frame: after 16 weeks of treatment]

Secondary Outcome(s)

Adverse events [Time Frame: No]

glucose profiles [Time Frame: No]

Hypoglycaemic events [Time Frame: No]

Quality of life assessment [Time Frame: No]

Treatment satisfaction [Time Frame: No]

Secondary ID(s)

AGEE-3017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors