Primary outcomeMean· Baseline to 12 weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
| Group | Value (percentage) | Spread |
|---|---|---|
| Sitagliptin | -1.08 | 0.13 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataContribution 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
NCTNCT01610154 (opens ClinicalTrials.gov in a new tab)Other idCIFuwaiHospital-MISP39889
This trial does not test a peptide that PepBank tracks.
- Measures Glucagon, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 85 participants (actual)
- Sponsor
- Guangwei Li · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
China
- Start
- Oct 2012
- Primary completion
- Aug 2014
- Completion
- Jun 2015
- First posted
- 1 Jun 2012 (estimated)
- Last update posted
- 11 May 2017
- Conditions
- Insulin Secretion · Insulin Resistance
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20122013201420152016
- Ph 4
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
NCT01610154Oct 2012 to Jun 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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) and overweight (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.
Interventions
- SitagliptinDrug
Arms1
Experimental
Sitagliptin treatment
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline to 12 weeks
Secondary outcomes(8)
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame · Baseline to 12 weeks
Change From Baseline in Postprandial Plasma Glucose (PPG)
Time frame · Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity
Time frame · Baseline to 12 weeks
Registry description
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Change From Baseline in Insulin Sensitivity in Patients With Different BMI
Time frame · Baseline to 12 weeks
Registry description
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Change From Baseline in Pancreatic β Cell Function
Time frame · Baseline to 12 weeks
Registry description
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
Time frame · Baseline to 12 weeks
Registry description
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Change From Baseline in Pancreatic α Cell Function
Time frame · Baseline to 12 weeks
Registry description
The glucagon-AUC was adopted to show pancreatic α cell function.
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
Time frame · Baseline to 12 weeks
Registry description
The glucagon-AUC was adopted to show pancreatic α cell function.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline to 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Sitagliptin | -1.99 | 0.18 |
Secondary outcomeMean· Baseline to 12 weeks
Change From Baseline in Postprandial Plasma Glucose (PPG)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Sitagliptin | -4.69 | 0.41 |
Secondary outcomeMedian· Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity
| Group | Value (mg/kg/min) |
|---|---|
| Sitagliptin | 0.64 |
Secondary outcomeMedian· Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity in Patients With Different BMI
| Group | Value (mg/kg/min) |
|---|---|
| Non-obese Group | 0.42 |
| Obese Group | 0.72 |
Secondary outcomeMedian· Baseline to 12 weeks
Change From Baseline in Pancreatic β Cell Function
| Group | Value (μu/ml/mmol) |
|---|---|
| Sitagliptin | 2.53 |
Secondary outcomeMedian· Baseline to 12 weeks
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
| Group | Value (μu/ml/mmol) |
|---|---|
| Non-obese Group | 2.30 |
| Obese Group | 2.85 |
Secondary outcomeMean· Baseline to 12 weeks
Change From Baseline in Pancreatic α Cell Function
| Group | Value (min∙pg/ml) | Spread |
|---|---|---|
| Sitagliptin | -27.8 | 32.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Sitagliptin TreatmentSitagliptin 100 mg QD | – | 0 / 84 | 8 / 84 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 25 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Age: 25\~60 years
2. Duration of disease \< 3 years,no drug treatment for diabetes
3. Newly diagnosed type 2 diabetic patients (fasting plasma glucose \> 7.0mmol/L or/and 2h postprandial blood glucose\>11.1mmol/L WHO 1999)
4. Fasting plasma glucose \< 10 mmol/L
Exclusion Criteria:
1. Type 1 diabetes
2. DKA, infection and other stress status
3. Autoimmune disease
4. Hepatic and renal diseases
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