Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

PHASE4CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

November 30, 2017

Study Completion Date

November 30, 2017

Conditions
Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver Disease
Interventions
DRUG

Exenatide

The starting dose of exenatide is 5 ug bid, subcutaneously, for 4 weeks, followed by 10 ug bid, subcutaneously, for 20 weeks. If hypoglycaemia (blood glucose\<2.9 mmol/l or \< 3.9 mmol/l at least 2 times) or serious intolerance occurs, the dose will be adjusted to 5 ug bid, subcutaneously.

DRUG

insulin glargine

"The starting dose of insulin glargine will depend upon the HbA1c level at screening(HbA1c \<8% use 0.1 -0.2 U/kg per day;HbA1c \>8% use 0.2 -0.3 U/kg per day).~Dose adjustment protocol for insulin glargine (at least 3 determinations of fasting blood glucose per week):~fasting blood glucose(FBG) \> 180 mg/dL(10 mmol/l): add 4 U; FBG 140-180 mg/dL(7.8-10 mmol/l): add 2 U; FBG 126-139 mg/dL(7.0-7.8 mmol/l): add 1 U.~If hypoglycemia, reduce insulin glargine by:~blood glucose \<70mg/dl(3.9mmol/l): 10%-20%; blood glucose \<40mg/dl(2.2mmol/l): 20%-40%."

Trial Locations (5)

200032

Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University, Shanghai

Unknown

Department of Endocrinology and Metabolism, Shanghai Minhang Central Hospital, Shanghai

Department of Endocrinology and Metabolism,Huadong Hospital, Shanghai

Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital, Shanghai

Department of Endocrinology and Metabolism,Shanghai Changzheng Hospital, Shanghai

All Listed Sponsors
collaborator

Huadong Hospital

OTHER

collaborator

Shanghai Minhang Central Hospital

OTHER

collaborator

Shanghai 6th People's Hospital

OTHER

collaborator

Shanghai Changzheng Hospital

OTHER

lead

Fudan University

OTHER

NCT02303730 - Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes | Biotech Hunter | Biotech Hunter