Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide | RxWiki

Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

Overview[ - collapse ][ - ]

Purpose	This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Drug: metformin
Phase	N/A
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00745433
First Received	September 1, 2008
Last Updated	June 5, 2012
Last verified	November 2011

Tracking Information[ + expand ][ + ]

First Received Date	September 1, 2008
Last Updated Date	June 5, 2012
Start Date	January 2008
Estimated Primary Completion Date	March 2009
Current Primary Outcome Measures	HbA1c [Time Frame: After 12-20 weeks.] [Designated as safety issue: No]
Current Secondary Outcome Measures	PPG [Time Frame: After 12-20 weeks.] [Designated as safety issue: No] Number of hypoglycemic events [Time Frame: After 12-20 weeks.] [Designated as safety issue: Yes] Variability in FPG (Fasting Plasma Glucose) [Time Frame: After 12-20 weeks.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide
Official Title	REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide
Brief Summary	This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice
Detailed Description	Not Provided
Study Type	Observational
Study Phase	N/A
Study Design	Time Perspective: Prospective
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Start dose and frequency at the discretion of the physician following clinical practice Other Names: NovoNorm®Drug: metformin Start dose and frequency at the discretion of the physician following clinical practice
Study Arm (s)	A Repaglinide add-on to metformin.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	906
Estimated Completion Date	March 2009
Estimated Primary Completion Date	March 2009
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes - Metformin monotreatment - HbA1c greater than 7% - Treatment according to SPC - Informed consent obtained Exclusion Criteria: - Any contraindication to the use of repaglinide (according to the SPC)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Belgium

Administrative Information[ + expand ][ + ]

NCT Number	NCT00745433
Other Study ID Numbers	AGEE-3558
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Dirk D'Hooge sa Novo Nordisk Pharma
Verification Date	November 2011

Locations[ + expand ][ + ]