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Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641407
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 31, 2008
Information provided by:
University of Campania "Luigi Vanvitelli"

Brief Summary:

The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications, but is difficult to achieve, despite the administration of escalating doses of oral antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal.

The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient who may benefit more by the single treatment.

This an open-label, randomized, parallel, 36-week comparative study was performed between January 2007 and March 2008 at a single centre.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypoglycemia Drug: NPL insulin Drug: Insulin glargine Phase 4

Detailed Description:
Patients were randomized to either NPL (Lilly) or glargine (Lantus, Aventis) to be administered subcutaneously at bedtime. Both insulin formulations consisted of cartridge containing 3 ML of either insulin preparation. Oral antihyperglycemic agents were continued at the prestudy dosages. No dietary advice was given beyond reinforcement of standard guidelines. The initial bedtime insulin dose was 10 IU for all patients with the goal to achieve a target FPG of < 100 mg/dL in both groups. The insulin dose was titrated weekly according to daily self-monitored fasting blood glucose measurements that provide values corresponding closely to laboratory measurements of plasma glucose. The patients were taught to increase their insulin dose by 2 IU if FPG was greater than 100 mg/dL, and by 4 IU if FPG was greater than 180 mg/dL on three consecutive mornings. Before the start of insulin therapy, and at weeks 12, 24 and 36, blood was withdrawn for measurements of full blood counts, electrolytes, creatinine, liver enzymes and lipids. Insulin doses, self-monitored plasma glucose (SMPG), and any events associated with signs or symptoms of hypoglycaemia were recorded in diaries.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bedtime Insulin Glargine or Bedtime Neutral Protamine Lispro Combined With Sulfonylurea and Metformin in Type 2 Diabetes. A Randomized, Controlled Trial
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: NPL insulin
Starting dose 10 IU bedtime and then titration

Active Comparator: 2 Drug: Insulin glargine
10 IU bedtime and then titration

Primary Outcome Measures :
  1. Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving HbA1c ≤7%, incidence of self-reported hypoglycaemic episodes, comparison of SMPG values from 8-point profiles, insulin doses, and body weight. [ Time Frame: 9 months ]

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women aged 30-70 years, with a duration of known diabetes > 2 years
  • And treated with stable doses of two oral antihyperglycemic agents (metformin and sulfonylurea) for at least 90 days were selected for the study
  • Body mass index less than 40 kg/m2
  • HbA1c level between 7.5 and 10%
  • And fasting plasma glucose of 120 mg/dL or greater.

Exclusion Criteria:

  • Exclusion criteria included pregnancy or breast-feeding
  • Previous use of insulin or other antihyperglycemic drugs
  • Investigational drug within the previous 3 months
  • Use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
  • Presence of any clinically relevant somatic or mental diseases
  • To minimize the likelihood of including subjects with late-onset type 1 diabetes
  • Candidate with a positive test for anti-GAD antibody or with fasting plasma C-peptide less than 0.25 pmol/ml were excluded
  • Also excluded were patients with abnormal safety laboratory tests
  • Including liver enzymes (ALT, AST, AFOS) higher than three times the upper limit of normal and serum creatinine > 1.4 mg/dL)
  • History of drug abuse
  • Poor compliance with the 8-point daily glucose profile measurement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641407

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Department of Geriatrics and Metabolic Disease
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
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Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and Metabolic Diseases

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Responsible Party: Dario Giugliano, MD, PhD, Department of Geriatrics and Metabolic Diseases Identifier: NCT00641407     History of Changes
Other Study ID Numbers: DGMM-01/2006
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008
Keywords provided by University of Campania "Luigi Vanvitelli":
Bedtime insulins
Poorly controlled type 2 diabetes
Glycemic control
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs