Cost Effectiveness of Glargine Insulin Versus NPH Insulin

NCT01832935 | Completed Phase 4 DMC

• 1 other identifier: 89-123
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail to achieve or sustain glycemic goals, insulin should be initiated. New insulin analogs are generated to improve glycemic control .New insulin analogs are generated to improve glycemic control,However, the cost of these analogs is a major problem .The aim of this piggy back evaluation was to assess the effect of Glargine insuline versus NPH plus regular human insulin on metabolic control as well as its cost-effectiveness in people with type 2 diabetes in the Iranian setting.

Conditions

Type 2 Diabetes Mellitus

Keywords

Glargin; NPH; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Number Of Hypoglycemic events

  The Number Of Hypoglycemic Events That Happend For Patients During Taking Both Insulines

  3 months

Study Arms (2)

insulin glargine

ACTIVE COMPARATOR

patients receiving variable doses of Insulin glargine.start with 0.2 to 0.6unit per kg

Drug: insulin glargine

Insulin NPH

ACTIVE COMPARATOR

patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg

Drug: Insulin NPH

Interventions

insulin glargine DRUG

The starting dose of insulin Glargine was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses

Also known as: Lantus

insulin glargine

Insulin NPH DRUG

The starting dose of insulin NPH was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses

Insulin NPH

Eligibility Criteria

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

You may qualify if:

• diabetes type 2
• HbA1c 8% or higher
• age 18 to 65

You may not qualify if:

• alteration in insulin sensitivity such as major surgery, infection, renal failure (Glomerular Filtration Rate \< 50),
• glucocorticoid treatment,
• recent (within 2 weeks) serious hypoglycemic episode (requires assistance of another),
• simultaneous participating in another clinical study,
• using any type of insulin,
• sight or hearing impaired,
• active proliferative retinopathy or maculopathy require treatment within 6 months prior to screening,
• breast feeding,
• pregnancy or nursing of the intention of becoming pregnant or
• not using adequate contraceptive measures.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 13145-784, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin, Isophane

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

• Alireza Esteghamati, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor alireza esteghamati

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 16, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

IR (1)