Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

NCT00641407 | Completed Phase 4

• 1 other identifier: DGMM-01/2006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Hypoglycemia

Keywords

Bedtime insulins; Poorly controlled type 2 diabetes; Glycemic control; HbA1c

Outcome Measures

Primary Outcomes (1)

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

  9 months

Secondary Outcomes (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.

  9 months

Study Arms (2)

1

EXPERIMENTAL

Drug: NPL insulin

2

ACTIVE COMPARATOR

Drug: Insulin glargine

Interventions

NPL insulin DRUG

Starting dose 10 IU bedtime and then titration

1

Insulin glargine DRUG

10 IU bedtime and then titration

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Department of Geriatrics and Metabolic Disease

Naples, 80138, Italy

Location

Related Publications (3)

• 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.

  PMID: 16456680 BACKGROUND

• 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.

  PMID: 12809451 BACKGROUND

• 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.

  PMID: 18165348 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

neutral protamine lispro insulin; Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dario Giugliano, MD,PhD

  Department of Geriatrics and Metabolic Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: January 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: March 1, 2008
• Last Updated: March 31, 2008

Record last verified: 2008-03

Locations

IT (1)