Type 2 diabetes/newly diagnosed non-obese
Conditions
Interventions
Group A:The dose of metformin will be initiated from 500 mg/day at dinner, and further titrated upward in 1500mg/day at 2-week intervals based on FPG values, to reach the fasting plasma glucose (FPG),
Group B:Glipizide GITS will be initially treated with 5 mg every morning to a dose of 15 mg/day. a.m. at 2-week intervals until to reach the fasting plasma glucose (FPG), assayed in samples obtained b
Group C:Combination of Glipizide GITS and metformin will be initially treated with 5 mg Glipizide GITS every morning and 500 mg/day metformin every dinner, and further titrated metformin upward to 150
Sponsors
Drum Tower Hospital Affiliated to Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities; 2. Newly diagnosed type 2 diabetic patients had not received anti-hyperglycaemic therapy; 3. Male or female to be aged from 25 years to 75 years old; 4. FPG levels between 7.0 and 13.0 mmol/l; 5. BMI 18.5 to 28 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to trial products or related products; 2. Impaired hepatic function defined as serum-creatinine >=1.5 mg/dl (>=133 umol/l); 3. Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock; 4. Hepatic insufficiency, acute alcohol intoxication, alcoholism; 5. Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhymias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class III and IV); 6. Proliferative retinopathy or muscular oedema requiring acute treatment; 7. Lactation; 8. Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to useadequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods); 9. Treatment with systemic corticosteroids within the past two months prior to screening; 10. Tested positive for glutamic acid decarboxylase antibody; 11. Receipt of any investigational drug within 1 month prior to this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;Achieve HbA1c < 7.0% and HbA1c < 6.5% of the propotion; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting proinsulin, proinsulin/insulin ratio;lipid profiles;fasting true insulin and C-peptide;2h-postprandial true insulin and C-peptide during;fasting and 2h-prandial plasma glucose during standard diet; | — |
Countries
China
Contacts
Public ContactDalong Zhu
Outcome results
None listed