Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

NCT01963728 | Terminated Phase 4 Results

• 1 other identifier: Inova NODAT-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).

Conditions

Diabetes Mellitus

Keywords

post-transplant; diabetes mellitus; renal transplant; kidney transplant; lung transplant; heart transplant; insulin

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1C (Glycosylated Hemoglobin)

  at 6 months post enrollment

Secondary Outcomes (1)

• Mean Blood Glucose Values

  3 and 6 months post enrollment

Study Arms (2)

insulin isophane

ACTIVE COMPARATOR

daily dose will be titrated based on fasting morning glucose values

Drug: Insulin, Isophane

insulin glargine

ACTIVE COMPARATOR

daily dose will be titrated based on fasting morning glucose values

Drug: insulin glargine

Interventions

Insulin, Isophane DRUG

daily dosing based on fasting morning glucose levels

Also known as: human NPH

insulin isophane

insulin glargine DRUG

daily dose based on fasting morning glucose levels

Also known as: Lantus

insulin glargine

Eligibility Criteria

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

You may qualify if:

• Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care
• Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication
• Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required)
• Ability to read consent form and give consent in English.

You may not qualify if:

• Use of insulin or non-insulin hypoglycemic medication before transplantation
• Cystic fibrosis patients
• Age \< 18 years of age
• Pregnancy
• Non-English speaking subjects

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance

Interventions

Insulin, Isophane; Isophane Insulin, Human; Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anne Whitney Brown, MD Principal Investigator
• Organization: Inova Health Care System

anne.brown@inova.org

703.776.3067

Study Officials

• Peter Ross, MD

  Inova Healthcare Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects will be randomized to 1. Insulin glargine (Lantus) or 2. Insulin isophane (NPH)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 16, 2013
• Study Start: November 27, 2013
• Primary Completion: April 9, 2015
• Study Completion: April 9, 2015
• Last Updated: July 26, 2022
• Results First Posted: January 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)