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

Diabetes Clinical Trial

Official title:

An Efficacy and Safety Comparison of Basal Insulin and OADs in Newly Diagnosed Type 2 Diabetes After Short-term Intensive Insulin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978263
• Other study ID #: ChongqingMU
• Status: Completed
• Phase: N/A
• First received: September 14, 2009
• Last updated: February 4, 2013
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• metformin-based Oral Antidiabetic Drugs

• Glargine

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Hemoglobin (HbA1c) at month 6		month 6	No
Primary	Change From Baseline in Glycosylated Hemoglobin at month 6		Baseline and month 6	No
Secondary	Glycosylated Hemoglobin at month 12		month 12	No
Secondary	Change From Baseline in Glycosylated Hemoglobin at month 12		Baseline and month 12	No
Secondary	Number of Participants With Glycosylated Hemoglobin = 7%		month 6	No
Secondary	Number of Participants With Glycosylated Hemoglobin = 7%		month 12	No
Secondary	Number of Participants With Glycosylated Hemoglobin = 6.5%		month 6	No
Secondary	Number of Participants With Glycosylated Hemoglobin = 6.5%		month 12	No
Secondary	Fasting Plasma Glucose at week 2		week 2	No
Secondary	Fasting Plasma Glucose at week 4		week 4	No
Secondary	Fasting Plasma Glucose at week 8		week 8	No
Secondary	Fasting Plasma Glucose at week 12		week 12	No
Secondary	Fasting Plasma Glucose at week 16		week 16	No
Secondary	Fasting Plasma Glucose at week 20		week 20	No
Secondary	Fasting Plasma Glucose at week 24		week 24	No
Secondary	Fasting Plasma Glucose at week 32		week 32	No
Secondary	Fasting Plasma Glucose at week 40		week 40	No
Secondary	Fasting Plasma Glucose at week 48		week 48	No
Secondary	Homeostasis model assessment (HOMA)-ß at month 6		month 6	No
Secondary	Insulinogenic index at month 6		month 6	No
Secondary	HOMA-IR at month 6		month 6	No
Secondary	Matsuda index at month 6		month 6	No
Secondary	Basal disposition index at month 6		month 6	No
Secondary	Early-phase disposition index at month 6		month 6	No
Secondary	Homeostasis model assessment (HOMA)-ß at month 12		month 12	No
Secondary	Insulinogenic index at month 12		month 12	No
Secondary	HOMA-IR at month 12		month 12	No
Secondary	Matsuda index at month 12		month 12	No
Secondary	Basal disposition index at month 12		month 12	No
Secondary	Early-phase disposition index at month 12		month 12	No
Secondary	Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score		month 6	No
Secondary	DTSQs score at month 12		month 12	No
Secondary	Audit of Diabetes Dependent Quality of Life (ADDQoL) score		month 6	No
Secondary	ADDQoL score at month 12		month 12	No
Secondary	Cost at month 6		month 6	No
Secondary	Number of Participants with Hypoglycemia		up to 6 month	Yes
Secondary	Number of hypoglycemia episodes		up to 6 month	Yes
Secondary	Number of Participants with severe Hypoglycemia		up to 6 month	Yes
Secondary	Number of severe hypoglycemia episodes		up to 6 month	Yes
Secondary	Change From Baseline in Body Weight (month 6)		Baseline and month 6	No
Secondary	Change From Baseline in Body Weight (month 12)		Baseline and month 12	No