Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)

NCT00529191 | Completed Phase 2 Results DMC

• 2 other identifiers: 2006-5-4824R01FD003340
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).

Conditions

Type 1 Diabetes

Keywords

Type I Diabetes (T1DM); Atorvastatin (Lipitor); Insulin; Pancreas; Beta Cells

Outcome Measures

Primary Outcomes (1)

• Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus

  The change in C-peptide measurements collected over a 4 hour period (0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes) after a Mixed Meal Tolerance Test at baseline vs 12 months post-treatment were calculated. The area under the curve for these combined measurements is calculated and the unit of measure is nanogram x minutes / mL. Efficacy (success) is defined by \< 7.5% reduction in AUC for 4-hr MMTT.

  Baseline vs 12-month

Secondary Outcomes (7)

• % Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months

  Baseline vs 12 months

• Mean Daily Insulin Dose Per kg Body Weight for 7 Days

  Visit 1, 2, 3, 4, 5, 6, 7

• Levels of HbA1c at Months 3, 6, 9, 12 and 18

  3, 6, 9, 12, and 18 months

• Blood Glucose Control (Number of Participants With Hypoglycemia)

  Baseline, Month 12, Month 18

• Number of Episodes of Hypoglycemia Requiring Any Treatment

  Baseline, Month 12, Month 18

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Two out of every three patients will receive atorvastatin.

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

One out of three subjects will receive a placebo.

Other: Placebo

Interventions

Atorvastatin DRUG

Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months

Also known as: Lipitor

Atorvastatin

Placebo OTHER

One out of three subjects will receive a placebo.

Placebo

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals 10-19 years of age (Tanner Stage II or greater),
• The presence of one or more serum antibodies to islet cell proteins (anti- glutamic acid decarboxylase \[GAD\], islet antigen 2 or insulin autoantibodies) as assessed in standard practice,
• Diagnosis of T1DM within the 8 weeks prior to study entry
• Peak stimulated C-peptide level \>0.2pmol/mL following mixed meal tolerance test (MMTT) performed at least 3 weeks after diagnosis,
• Females of reproductive potential must not plan on conceiving a child during the treatment program, and agree to use a medically accepted form of contraception

You may not qualify if:

• Subjects currently receiving cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, clarythromycin, nefazodone, itraconazole, ketoconazole or protease inhibitors,
• Pregnancy or breast-feeding,
• Clinical AIDS, AIDS related syndrome (ARS) or known positive HIV serology,
• Subjects treated with immunosuppressive therapy in the past 12 months,
• Subjects receiving glucocorticoid therapy or therapy other than insulin that is likely to affect glucose homeostasis (such as sulfonylureas, thiazolidinediones, metformin or amylin),
• Subjects with other autoimmune diseases, except autoimmune thyroid disease,
• Subjects with any illness that might complicate diabetes management or preclude treatment with atorvastatin,
• Transplant recipients,
• Evidence of liver dysfunction or myopathy

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• FDA Office of Orphan Products Development: collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

Diabetes Center for Children & Clinical Translational Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Steven Willi, MD
• Organization: Children's Hospital of Philadelphia

willi@chop.email.edu

215-590-3174

Study Officials

• Steven M Willi, M.D

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2013
• Last Updated: March 13, 2017
• Results First Posted: March 8, 2013

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)