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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Glargine; Drug: metformin-based Oral Antidiabetic Drugs

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Glargine; Other Names: Lantus
Experimental: 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.	Drug: metformin-based Oral Antidiabetic Drugs; Other Names: Metformin and so on

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycosylated Hemoglobin (HbA1c) at month 6	month 6
Change From Baseline in Glycosylated Hemoglobin at month 6	Baseline and month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Glycosylated Hemoglobin at month 12	month 12
Change From Baseline in Glycosylated Hemoglobin at month 12	Baseline and month 12
Number of Participants With Glycosylated Hemoglobin ≤ 7%	month 6
Number of Participants With Glycosylated Hemoglobin ≤ 7%	month 12
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%	month 6
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%	month 12
Fasting Plasma Glucose at week 2	week 2
Fasting Plasma Glucose at week 4	week 4
Fasting Plasma Glucose at week 8	week 8
Fasting Plasma Glucose at week 12	week 12
Fasting Plasma Glucose at week 16	week 16
Fasting Plasma Glucose at week 20	week 20
Fasting Plasma Glucose at week 24	week 24
Fasting Plasma Glucose at week 32	week 32
Fasting Plasma Glucose at week 40	week 40
Fasting Plasma Glucose at week 48	week 48
Homeostasis model assessment (HOMA)-β at month 6	month 6
Insulinogenic index at month 6	month 6
HOMA-IR at month 6	month 6
Matsuda index at month 6	month 6
Basal disposition index at month 6	month 6
Early-phase disposition index at month 6	month 6
Homeostasis model assessment (HOMA)-β at month 12	month 12
Insulinogenic index at month 12	month 12
HOMA-IR at month 12	month 12
Matsuda index at month 12	month 12
Basal disposition index at month 12	month 12
Early-phase disposition index at month 12	month 12
Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score	month 6
DTSQs score at month 12	month 12
Audit of Diabetes Dependent Quality of Life (ADDQoL) score	month 6
ADDQoL score at month 12	month 12
Cost at month 6	month 6
Number of Participants with Hypoglycemia	up to 6 month
Number of hypoglycemia episodes	up to 6 month
Number of Participants with severe Hypoglycemia	up to 6 month
Number of severe hypoglycemia episodes	up to 6 month
Change From Baseline in Body Weight (month 6)	Baseline and month 6
Change From Baseline in Body Weight (month 12)	Baseline and month 12

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Principal Investigator: Qifu Li, PhD, the First Affiliated Hospital, Chongqing Medical University, China

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimate): September 16, 2009

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: ChongqingMU