Phase 4
N=85
Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
Insulin Secretion · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT01610154 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline in Hemoglobin A1c (HbA1c) — -1.08 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Guangwei Li
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-1.08 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-1.99 | — |
| SECONDARY Change From Baseline in Postprandial Plasma Glucose (PPG) |
-4.69 | — |
| SECONDARY Change From Baseline in Insulin Sensitivity |
0.64 | — |
| SECONDARY Change From Baseline in Insulin Sensitivity in Patients With Different BMI |
0.42; 0.72 | — |
| SECONDARY Change From Baseline in Pancreatic β Cell Function |
2.53 | — |
| SECONDARY Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI |
2.30; 2.85 | — |
| SECONDARY Change From Baseline in Pancreatic α Cell Function |
-27.8 | — |
| SECONDARY Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI |
13.6; -54.0 | — |
Summary
1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.
2. There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha & beta cell function are different in lean (BMI 25) Chinese type 2 diabetics.
3. The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.
Eligibility Criteria
Inclusion Criteria
- Age: 25~60 years
- Duration of disease 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)
- Fasting plasma glucose < 10 mmol/L
Exclusion Criteria
- Type 1 diabetes
- DKA, infection and other stress status
- Autoimmune disease
- Hepatic and renal diseases
Data sourced from ClinicalTrials.gov (NCT01610154). 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.