Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs | RxWiki

Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

Overview[ - collapse ][ - ]

Purpose	This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Drug: metformin
Phase	Phase 4
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00491725
First Received	June 25, 2007
Last Updated	January 23, 2012
Last verified	January 2012

Tracking Information[ + expand ][ + ]

First Received Date	June 25, 2007
Last Updated Date	January 23, 2012
Start Date	September 2005
Estimated Primary Completion Date	June 2006
Current Primary Outcome Measures	HbA1c [Time Frame: after 18 weeks of treatment] [Designated as safety issue: No]
Current Secondary Outcome Measures	Post Prandial Plasma Glucose [Designated as safety issue: No] Fasting Plasma Glucose (FPG) [Designated as safety issue: No] Safety profile [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs
Official Title	A Multi-centre, Single Armed, Open Labelled Trial to Study the Efficacy and Safety Profile of Repaglinide & Metformin Combination Therapy in Chinese Type 2 Diabetics
Brief Summary	This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Drug: metformin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	187
Estimated Completion Date	June 2006
Estimated Primary Completion Date	June 2006
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes for at least 12 weeks - HbA1c: 8.0-10.0% - Current treatment with OAD on monotheray or OAD on combination therapy - Body mass index (BMI): 21.0-35.0 kg/m2 Exclusion Criteria: - Known or suspected allergy to trial product(s) or related products - Recurrent major hypoglycaemia as judged by the Investigator - Uncontrolled hypertension - Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator
Gender	Both
Ages	35 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT00491725
Other Study ID Numbers	AGEE-1655
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: JIN Pingping, Bsc Novo Nordisk A/S
Verification Date	January 2012

Locations[ + expand ][ + ]