Clinical trial NCT00819741: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-01-09
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: week -2 (screening), week 16
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: week 0, week 16
measure: Change in 2-hour Postprandial Plasma Glucose
timeFrame: Week 0, week 16
measure: Change in 7-point Plasma Glucose Profile
timeFrame: Week 0, week 16
measure: Change in Fasting Serum Insulin
timeFrame: Week 0, week 16
measure: Change in 2-hour Postprandial Serum Insulin
timeFrame: Week 0, week 16
measure: Change in Fasting Serum C-peptide
timeFrame: Week 0, week 16
measure: Change in 2-hour Postprandial Serum C-peptide
timeFrame: Week 0, week 16
measure: Hypoglycaemic Episodes
timeFrame: Weeks 0-16
measure: Change in Blood Pressure
timeFrame: Week 0, week 16
measure: Physical Examinations
timeFrame: Week -2, week 16
measure: ECG (ElectroCardioGram)
timeFrame: Week -2, week 16
measure: Biochemistry: Alanine Aminotransferase (ALAT)
timeFrame: Week -2, week 16
measure: Biochemistry: Alanine Aminotransferase (ASAT)
timeFrame: Week -2, week 16
measure: Haematology: Haemoglobin
timeFrame: Week -2, week 16
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Novo Nordisk Investigational Site
state: Fujian
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Wuxi
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Hangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
city: Wenzhou
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novo Nordisk Investigational Site
city: Nantong
country: China
facility: Novo Nordisk Investigational Site
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Wang W, Bu R, Su Q, Liu J, Ning G. Randomized study of repaglinide alone and in combination with metformin in Chinese subjects with type 2 diabetes naive to oral antidiabetes therapy. Expert Opin Pharmacother. 2011 Dec;12(18):2791-9. doi: 10.1517/14656566.2011.602341. Epub 2011 Jul 22.