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
  Purpose

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.


Condition Intervention
Diabetes
Drug: metformin-based Oral Antidiabetic Drugs
Drug: Glargine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Comparison of Basal Insulin and OADs in Newly Diagnosed Type 2 Diabetes After Short-term Intensive Insulin Therapy

Resource links provided by NLM:


Further study details as provided by Chongqing Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Metformin and so on

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978263

Locations
China, Chongqing
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University
Investigators
Principal Investigator: Qifu Li, PhD the First Affiliated Hospital, Chongqing Medical University, China
  More Information

No publications provided

Responsible Party: Qifu Li, Department of Endocrinology, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT00978263     History of Changes
Other Study ID Numbers: ChongqingMU
Study First Received: September 14, 2009
Last Updated: February 4, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014