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

NCT00978263 | Completed DMC

• 1 other identifier: ChongqingMU
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

• Glycosylated Hemoglobin (HbA1c) at month 6

  month 6

• Change From Baseline in Glycosylated Hemoglobin at month 6

  Baseline and month 6

Secondary Outcomes (39)

• 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

Study Arms (2)

Glargine

EXPERIMENTAL

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

metformin-based Oral Antidiabetic Drugs

EXPERIMENTAL

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

Interventions

metformin-based Oral Antidiabetic Drugs DRUG

Also known as: Metformin and so on

metformin-based Oral Antidiabetic Drugs

Glargine DRUG

Also known as: Lantus

Glargine

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed type 2 diabetic patients.
• Drug naïve, with severe hyperglycemia (fasting plasma glucose\>11.1mmol/L or random plasma glucose \>16.7mmol/L)
• Those who age between 30 and 70 years old and can inject insulin by themselves.

You may not qualify if:

• Established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;
• Malignancy, pregnancy or lactating;
• History of ketoacidosis;
• Hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine \>2 mg/dl;
• Poor blood pressure control (SBP\>180mmHg or DBP \>110mmHg);
• Definite coronary artery disease, heart failure, left ventricular hypertrophy;
• Severe anemia; acute or severe chronic diabetes complications;
• BMI\<18 kg/m2 or ≥41kg/m2;
• History of alcohol abuse or drug abuse;
• Mental disorder and other endocrine disorders; dysfunction of digestion and absorption;
• Chronic diseases need long-term glucocorticoid treatment.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Qifu Li, PhD

  the First Affiliated Hospital, Chongqing Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Endocrinology

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 16, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

CN (1)