N/A
Completed N=416
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
Type 2 Diabetes Mellitus · Newly Diagnosed
Source: ClinicalTrials.gov NCT01147627 ↗
Enrolled (actual)
416
Serious AEs
3.1%
Results posted
Aug 2013
Primary outcomePrimary: the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks — -1.8; -1.74; -1.47 percentage of HbA1c — p=<0.05
Summary
The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks |
-1.8; -1.74; -1.47 | <0.05 sig |
| SECONDARY Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles |
— | — |
| SECONDARY β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio) |
— | — |
| SECONDARY Safety and Tolerability in Different Groups |
— | — |
Eligibility Criteria
Inclusion Criteria
- newly-diagnosed type 2 diabetic patients, drug naïve
- age 30~70 years
- HbA1c 7.0~10.0%
- BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
- female patients of reproductive age should practice a reliable method of birth control throughout the study
Exclusion Criteria
- acute or severe chronic diabetic complications
- congestive heart failure (NYHA grade Ⅲ~Ⅳ)
- severe gastrointestinal disease
- severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
- other severe intercurrent illness
- serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
- tested positive for glutamic acid decarboxylase antibody
- use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
- history of pancreatitis
- serum triglyceride ≥ 5.0 mmol/L
- pregnancy
Data sourced from ClinicalTrials.gov (NCT01147627). 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.