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Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus, Hypoglycemia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
NPL insulin
Insulin glargine
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Bedtime insulins, Poorly controlled type 2 diabetes, Glycemic control, HbA1c

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Geriatrics and Metabolic Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group.

Secondary Outcome Measures

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.

Full Information

First Posted
March 17, 2008
Last Updated
March 28, 2008
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT00641407
Brief Title
Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
Official Title
Bedtime Insulin Glargine or Bedtime Neutral Protamine Lispro Combined With Sulfonylurea and Metformin in Type 2 Diabetes. A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Hypoglycemia
Keywords
Bedtime insulins, Poorly controlled type 2 diabetes, Glycemic control, HbA1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
NPL insulin
Intervention Description
Starting dose 10 IU bedtime and then titration
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Intervention Description
10 IU bedtime and then titration
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Giugliano, MD,PhD
Organizational Affiliation
Department of Geriatrics and Metabolic Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Geriatrics and Metabolic Disease
City
Naples
ZIP/Postal Code
80138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16456680
Citation
Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M, Vahatalo M, Virtamo H, Nikkila K, Tulokas T, Hulme S, Hardy K, McNulty S, Hanninen J, Levanen H, Lahdenpera S, Lehtonen R, Ryysy L. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006 Mar;49(3):442-51. doi: 10.1007/s00125-005-0132-0. Epub 2006 Feb 3.
Results Reference
background
PubMed Identifier
12809451
Citation
Fritsche A, Schweitzer MA, Haring HU; 4001 Study Group. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med. 2003 Jun 17;138(12):952-9. doi: 10.7326/0003-4819-138-12-200306170-00006.
Results Reference
background
PubMed Identifier
18165348
Citation
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008 Jan;31(1):173-5. doi: 10.2337/dc08-9016. No abstract available.
Results Reference
background

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Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

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