Clinical trial NCT00978263: Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes
Official title: An Efficacy and Safety Comparison of Basal Insulin and OADs in Newly Diagnosed Type 2 Diabetes After Short-term Intensive Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c) at month 6
timeFrame: month 6
measure: Change From Baseline in Glycosylated Hemoglobin at month 6
timeFrame: Baseline and month 6
Secondary outcomes:
measure: Glycosylated Hemoglobin at month 12
timeFrame: month 12
measure: Change From Baseline in Glycosylated Hemoglobin at month 12
timeFrame: Baseline and month 12
measure: Number of Participants With Glycosylated Hemoglobin ≤ 7%
timeFrame: month 6
measure: Number of Participants With Glycosylated Hemoglobin ≤ 7%
timeFrame: month 12
measure: Number of Participants With Glycosylated Hemoglobin ≤ 6.5%
timeFrame: month 6
measure: Number of Participants With Glycosylated Hemoglobin ≤ 6.5%
timeFrame: month 12
measure: Fasting Plasma Glucose at week 2
timeFrame: week 2
measure: Fasting Plasma Glucose at week 4
timeFrame: week 4
measure: Fasting Plasma Glucose at week 8
timeFrame: week 8
measure: Fasting Plasma Glucose at week 12
timeFrame: week 12
measure: Fasting Plasma Glucose at week 16
timeFrame: week 16
measure: Fasting Plasma Glucose at week 20
timeFrame: week 20
measure: Fasting Plasma Glucose at week 24
timeFrame: week 24
measure: Fasting Plasma Glucose at week 32
timeFrame: week 32
measure: Fasting Plasma Glucose at week 40
timeFrame: week 40
measure: Fasting Plasma Glucose at week 48
timeFrame: week 48
measure: Homeostasis model assessment (HOMA)-β at month 6
timeFrame: month 6
measure: Insulinogenic index at month 6
timeFrame: month 6
measure: HOMA-IR at month 6
timeFrame: month 6
measure: Matsuda index at month 6
timeFrame: month 6
measure: Basal disposition index at month 6
timeFrame: month 6
measure: Early-phase disposition index at month 6
timeFrame: month 6
measure: Homeostasis model assessment (HOMA)-β at month 12
timeFrame: month 12
measure: Insulinogenic index at month 12
timeFrame: month 12
measure: HOMA-IR at month 12
timeFrame: month 12
measure: Matsuda index at month 12
timeFrame: month 12
measure: Basal disposition index at month 12
timeFrame: month 12
measure: Early-phase disposition index at month 12
timeFrame: month 12
measure: Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score
timeFrame: month 6
measure: DTSQs score at month 12
timeFrame: month 12
measure: Audit of Diabetes Dependent Quality of Life (ADDQoL) score
timeFrame: month 6
measure: ADDQoL score at month 12
timeFrame: month 12
measure: Cost at month 6
timeFrame: month 6
measure: Number of Participants with Hypoglycemia
timeFrame: up to 6 month
measure: Number of hypoglycemia episodes
timeFrame: up to 6 month
measure: Number of Participants with severe Hypoglycemia
timeFrame: up to 6 month
measure: Number of severe hypoglycemia episodes
timeFrame: up to 6 month
measure: Change From Baseline in Body Weight (month 6)
timeFrame: Baseline and month 6
measure: Change From Baseline in Body Weight (month 12)
timeFrame: Baseline and month 12
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: the First Affiliated Hospital, Chongqing Medical University, China
name: Qifu Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: