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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819741
• Other study ID #: AGEE-3705
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2009
• Last updated: June 5, 2012
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: June 2012
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• 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
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin A1c (HbA1c)	Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.	week -2 (screening), week 16	No
Secondary	Change in Fasting Plasma Glucose	Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.	week 0, week 16	No
Secondary	Change in 2-hour Postprandial Plasma Glucose	Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment	Week 0, week 16	No
Secondary	Change in 7-point Plasma Glucose Profile	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.	Week 0, week 16	No
Secondary	Change in Fasting Serum Insulin	Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.	Week 0, week 16	No
Secondary	Change in 2-hour Postprandial Serum Insulin	Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.	Week 0, week 16	No
Secondary	Change in Fasting Serum C-peptide	Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment	Week 0, week 16	No
Secondary	Change in 2-hour Postprandial Serum C-peptide	Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment	Week 0, week 16	No
Secondary	Hypoglycaemic Episodes	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.	Weeks 0-16	No
Secondary	Change in Blood Pressure	Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment	Week 0, week 16	No
Secondary	Physical Examinations	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.	Week -2, week 16	No
Secondary	ECG (ElectroCardioGram)	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.	Week -2, week 16	No
Secondary	Biochemistry: Alanine Aminotransferase (ALAT)	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.	Week -2, week 16	No
Secondary	Biochemistry: Alanine Aminotransferase (ASAT)	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.	Week -2, week 16	No
Secondary	Haematology: Haemoglobin	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.	Week -2, week 16	No

External Links

•   Clinical Trials at Novo Nordisk