Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs | RxWiki

Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs

Overview[ - collapse ][ - ]

Purpose	This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide Drug: metformin Drug: repaglinide
Phase	Phase 4
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00819741
First Received	January 8, 2009
Last Updated	June 5, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	January 8, 2009
Last Updated Date	June 5, 2012
Start Date	February 2009
Estimated Primary Completion Date	November 2009
Current Primary Outcome Measures	Change in Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: week -2 (screening), week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
Current Secondary Outcome Measures	Change in Fasting Plasma Glucose [Time Frame: week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment. Change in 2-hour Postprandial Plasma Glucose [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment Change in 7-point Plasma Glucose Profile [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment. Change in Fasting Serum Insulin [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment. Change in 2-hour Postprandial Serum Insulin [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment. Change in Fasting Serum C-peptide [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment Change in 2-hour Postprandial Serum C-peptide [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment Hypoglycaemic Episodes [Time Frame: Weeks 0-16] [Designated as safety issue: No]Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Change in Blood Pressure [Time Frame: Week 0, week 16] [Designated as safety issue: No]Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment Physical Examinations [Time Frame: Week -2, week 16] [Designated as safety issue: No]The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen. ECG (ElectroCardioGram) [Time Frame: Week -2, week 16] [Designated as safety issue: No]The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. Biochemistry: Alanine Aminotransferase (ALAT) [Time Frame: Week -2, week 16] [Designated as safety issue: No]The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. Biochemistry: Alanine Aminotransferase (ASAT) [Time Frame: Week -2, week 16] [Designated as safety issue: No]The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management. Haematology: Haemoglobin [Time Frame: Week -2, week 16] [Designated as safety issue: No]Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

Descriptive Information[ + expand ][ + ]

Brief Title	Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
Official Title	A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients
Brief Summary	This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: repaglinide The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily Drug: metformin The dose was started from repaglinide 1 mg plus metformin 500 mg once daily. During the dose titration period, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose. the minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily Drug: repaglinide The dose was started from repaglinide 1 mg three times daily. During the dose titration period, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose.
Study Arm (s)	Experimental: Repaglinide + metformin Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily. Active Comparator: Repaglinide Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	433
Estimated Completion Date	November 2009
Estimated Primary Completion Date	November 2009
Eligibility Criteria	Inclusion Criteria: - Diagnosed with type 2 diabetes - Never taken oral antidiabetic drugs before - HbA1c greater than 8.5 % - BMI (Body Mass Index) less than or equal to 35 kg/m^2 Exclusion Criteria: - Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications - Taken an investigational drug in another clinical trial within 4 weeks prior to this trial - Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit - Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems - Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg) - Impaired renal function - Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine - Have a clinically significant, active cardiovascular disease, or decompensated heart failure - Treatment with systemic corticosteroids within the past two months prior to screening
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT00819741
Other Study ID Numbers	AGEE-3705
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Xiaohui GAO, MS Novo Nordisk A/S
Verification Date	June 2012

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