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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT00978263
First received: September 14, 2009
Last updated: February 4, 2013
Last verified: February 2013

September 14, 2009
February 4, 2013
February 2009
December 2011   (final data collection date for primary outcome measure)
  • Glycosylated Hemoglobin (HbA1c) at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Glycosylated Hemoglobin at month 6 [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00978263 on ClinicalTrials.gov Archive Site
  • Glycosylated Hemoglobin at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in Glycosylated Hemoglobin at month 12 [ Time Frame: Baseline and month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Glycosylated Hemoglobin ≤ 7% [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Number of Participants With Glycosylated Hemoglobin ≤ 7% [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Glycosylated Hemoglobin ≤ 6.5% [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Number of Participants With Glycosylated Hemoglobin ≤ 6.5% [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 16 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 20 [ Time Frame: week 20 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 32 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 40 [ Time Frame: week 40 ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose at week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Homeostasis model assessment (HOMA)-β at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Insulinogenic index at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • HOMA-IR at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Matsuda index at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Basal disposition index at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Early-phase disposition index at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Homeostasis model assessment (HOMA)-β at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Insulinogenic index at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • HOMA-IR at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Matsuda index at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Basal disposition index at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Early-phase disposition index at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • DTSQs score at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Audit of Diabetes Dependent Quality of Life (ADDQoL) score [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • ADDQoL score at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Cost at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Number of Participants with Hypoglycemia [ Time Frame: up to 6 month ] [ Designated as safety issue: Yes ]
  • Number of hypoglycemia episodes [ Time Frame: up to 6 month ] [ Designated as safety issue: Yes ]
  • Number of Participants with severe Hypoglycemia [ Time Frame: up to 6 month ] [ Designated as safety issue: Yes ]
  • Number of severe hypoglycemia episodes [ Time Frame: up to 6 month ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Weight (month 6) [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight (month 12) [ Time Frame: Baseline and month 12 ] [ Designated as safety issue: No ]
  • the β-cell function and insulin sensitivity [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]
  • Development of diabetic complications [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes
  • Drug: metformin-based Oral Antidiabetic Drugs
    Other Name: Metformin and so on
  • Drug: Glargine
    Other Name: Lantus
  • 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.
    Intervention: Drug: Glargine
  • 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.
    Intervention: Drug: metformin-based Oral Antidiabetic Drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
June 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00978263
ChongqingMU
Yes
Qifu Li, Chongqing Medical University
Chongqing Medical University
Not Provided
Principal Investigator: Qifu Li, PhD the First Affiliated Hospital, Chongqing Medical University, China
Chongqing Medical University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP