Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

NCT03325114 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 662821K23DK114477-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label study will determine if chlorthalidone is safe and effective for the use of reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes

Conditions

Type 1 Diabetes Mellitus; Hypercalciuria

Keywords

type 1 diabetes; hypercalciuria

Outcome Measures

Primary Outcomes (4)

• Urinary Calcium Excretion

  Change in 24 hour urine calcium excretion

  Assessed at baseline and at 4 weeks

• Hypokalemia

  Serum potassium decreased to \<3.5 milliequivalent/L

  Assessed weekly for up to 4 weeks or until hypokalemia develops

• Hypercalcemia

  Serum calcium increased to \>10.5 mg/dL

  Assessed weekly for up to 4 weeks or until hypercalcemia develops

• Hyperglycemia

  Change in serum fructosamine

  Assessed at baseline and at 4 weeks

Study Arms (1)

Chlorthalidone

OTHER

Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks

Drug: Chlorthalidone

Interventions

Chlorthalidone DRUG

Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks

Chlorthalidone

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of T1D
• Age 12-21 years
• Tanner Stage 2 or greater pubertal development
• Urine calcium excretion ≥ 4 mg/kg/day
• Able to swallow pills

You may not qualify if:

• BMI \> 99th percentile for age (\<18 years) or BMI \>35 kg/m2 (≥ 18 years)
• Coexistent conditions that may affect calcium metabolism including:
• celiac disease
• Graves' Disease
• Addison's disease
• hypo- or hyperparathyroidism
• History of diabetes related complications including:
• neuropathy
• retinopathy
• nephropathy
• gastroparesis
• History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within the past month
• History of any diuretic use within the past month
• Laboratory abnormalities on screening bloodwork including:
• estimated glomerular filtration rate \<90 mL/min per 1.73 m2 of body surface area

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypercalciuria

Interventions

Chlorthalidone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Carrie Dykes
• Organization: University of Rochester

carrie_dykes@urmc.rochester.edu

15852750736

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: June 28, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)