Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes

NCT ID: NCT00978263

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-06-30

Brief Summary

The investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.

Detailed Description

Detailed Description:

OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin sensitivity. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify whether basal insulin glargine or metformin-based OADs for further management would have a long-term benefit in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients (fasting blood glucose >200 mg/dL or random blood glucose >300 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. HbA1c were measured before intensive insulin injection. After discharge, patients will be randomized to receive basal insulin injection or metformin-based OADs for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. HbA1c were measured 6 months later.After the six-month intervention, these patients were continually followed up for another six months. Subjects received an oral glucose tolerance test (OGTT) after the intensive insulin therapy and at the end of the 6th and 12th month.

EXPECTED RESULTS-We will expect that basal insulin glargine,compared with metformin-based OAD treatment,could more effectively maintain adequate glycemic control in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glargine

Initial basal Insulin therapy was according to the dose administrated at bedtime in the last day hospitalization. basal Insulin doses were titrated every 3 days to achieve target FPG values between 80 and 130 mg/dl.

Group Type: EXPERIMENTAL

Glargine

Intervention Type: DRUG

metformin-based Oral Antidiabetic Drugs

Subject in metformin-based OAD group was visited every two weeks in the first month and the every four weeks for another five months. The subjects will start with Metformin 425mg bid, The dosage was titrated (up to 850mg bid) based on the fasting blood glucose every two weeks. If the patients fail to achieve the target, gliclazide-MR (Diamicron, Servier), or glimepiride (Amaryl, Sanofi-Aventis) would be added.

Group Type: EXPERIMENTAL

metformin-based Oral Antidiabetic Drugs

Intervention Type: DRUG

Interventions

metformin-based Oral Antidiabetic Drugs

Intervention Type: DRUG

Glargine

Intervention Type: DRUG

Other Intervention Names

Metformin and so on; Lantus

Eligibility Criteria

Inclusion Criteria

1. Newly diagnosed type 2 diabetic patients.

2. Drug naïve, with severe hyperglycemia (fasting plasma glucose>11.1mmol/L or random plasma glucose >16.7mmol/L)

3. Those who age between 30 and 70 years old and can inject insulin by themselves.

Exclusion Criteria

1. Established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;

2. Malignancy, pregnancy or lactating;

3. History of ketoacidosis;

4. Hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine >2 mg/dl;

5. Poor blood pressure control (SBP>180mmHg or DBP >110mmHg);

6. Definite coronary artery disease, heart failure, left ventricular hypertrophy;

7. Severe anemia; acute or severe chronic diabetes complications;

8. BMI<18 kg/m2 or ≥41kg/m2;

9. History of alcohol abuse or drug abuse;

10. Mental disorder and other endocrine disorders; dysfunction of digestion and absorption;

11. Chronic diseases need long-term glucocorticoid treatment.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qifu Li

Department of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qifu Li, PhD

Role: PRINCIPAL_INVESTIGATOR

the First Affiliated Hospital, Chongqing Medical University, China

Locations

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

ChongqingMU

Identifier Type: -

Identifier Source: org_study_id