Phase 4
Completed N=433
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
Source: ClinicalTrials.gov NCT00819741 ↗Enrolled (actual)
433
Serious AEs
0.2%
Results posted
Dec 2010
Primary outcomePrimary: Change in Glycosylated Haemoglobin A1c (HbA1c) — -4.450; -4.148 percentage (%) of total haemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin A1c (HbA1c) |
-4.450; -4.148 | — |
| SECONDARY Change in Fasting Plasma Glucose |
-4.646; -3.982 | — |
| SECONDARY Change in 2-hour Postprandial Plasma Glucose |
-7.525; -6.794 | — |
| SECONDARY Change in 7-point Plasma Glucose Profile |
-4.99; -4.58; -7.85; -7.40; -6.85; -6.28 | — |
| SECONDARY Change in Fasting Serum Insulin |
3.163; 5.694 | — |
| SECONDARY Change in 2-hour Postprandial Serum Insulin |
34.083; 28.548 | — |
| SECONDARY Change in Fasting Serum C-peptide |
0.041; 0.405 | — |
| SECONDARY Change in 2-hour Postprandial Serum C-peptide |
2.301; 2.081 | — |
| SECONDARY Hypoglycaemic Episodes |
0; 0; 41; 16; 90; 71 | — |
| SECONDARY Change in Blood Pressure |
-1.0; -0.9; -1.5; -1.4 | — |
| SECONDARY Physical Examinations |
3; 0 | — |
| SECONDARY ECG (ElectroCardioGram) |
3; 2 | — |
| SECONDARY Biochemistry: Alanine Aminotransferase (ALAT) |
4; 5 | — |
| SECONDARY Biochemistry: Alanine Aminotransferase (ASAT) |
2; 4 | — |
| SECONDARY Haematology: Haemoglobin |
1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00819741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.