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 (Nil)

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: repaglinide (Drug); metformin (Drug); repaglinide (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Xiaohui GAO, MS, Study Director, Affiliation: Novo Nordisk

Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

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 type 2 diabetic patients with an HbA1c 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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c change from baseline

Secondary outcome:

Fasting glucose change from baseline

2-h postprandial plasma glucose changes

7-point plasma glucose profile change from baseline

Hypoglycaemic episodes

Fasting and 2-h postprandial serum insulin changes

Fasting and 2-h postprandial serum C-peptide changes

Standard safety parameters (including vital signs, physical examinations, ECG, hematology and biochemistry)Trial design

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with type 2 diabetes

- Never taken oral antidiabetic drugs before

- HbA1c greater than 8. 5 %

- BMI less than or equal to 35 kg/m2

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 or ALAT 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 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

Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

Shanghai 200025, China

Clinical Trials at Novo Nordisk

Starting date: February 2009
Ending date: November 2009
Last updated: January 27, 2009