Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

NCT00564018 | Terminated Results

• 2 other identifiers: UTSW-052006-056816
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether using a long-acting insulin analog at the time of diagnosis, instead of intermediate-acting insulin, affects the rate of loss of the body's ability to make insulin in children with newly diagnosed type 1 diabetes.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes, basal-bolus, honeymoon, C-peptide

Outcome Measures

Primary Outcomes (1)

• C-peptide Area Under the Curve

  We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis.

  Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis

Secondary Outcomes (1)

• Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis

  6 months

Study Arms (3)

Detemir

EXPERIMENTAL

24 subjects randomized to therapy with a combination of insulins detemir and aspart at diagnosis of diabetes.

Drug: Insulin detemir

Glargine

EXPERIMENTAL

24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes.

Drug: Glargine

NPH

EXPERIMENTAL

24 subjects randomized to therapy with a combination of insulins NPH and aspart at diagnosis of diabetes.

Drug: NPH

Interventions

Insulin detemir DRUG

Dosage adjusted to meet age-specific glycemic goals throughout course of study.

Also known as: Levemir

Detemir

Glargine DRUG

Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.

Also known as: Lantus

Glargine

NPH DRUG

Dosage to be adjusted to meet age specific glycemic goals throughout course of study.

Also known as: Neutral Protamine Hagedorn

NPH

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed type 1 diabetes within 1 week of diagnosis
• Age 6 - 18 years
• Care provided at Children's Medical Center, Dallas

You may not qualify if:

• Actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents)
• Actual treatment with drugs influencing insulin sensitivity (e.g. Metformin, or systemic steroids)
• Significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry)
• Expected poor compliance
• Pregnancy
• Any other condition that by the judgement of the investigator may be potentially harmful to the patients

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Detemir; Insulin Glargine; Insulin, Isophane

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Interpretation of the data is limited by the small sample sizes due to early study termination

Results Point of Contact

• Title: Soumya Adhikari, MD
• Organization: UT Southwestern Medical Center

soumya.adhikari@utsouthwestern.edu

214 456 5959

Study Officials

• Soumya Adhikari, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: September 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2011
• Last Updated: October 11, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-10

Locations

US (1)