Trial Outcomes & Findings for Safety and Efficacy of Chlorthalidone in Type 1 Diabetes (NCT NCT03325114)

Results Overview

Change in 24 hour urine calcium excretion

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Assessed at baseline and at 4 weeks

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Chlorthalidone Chlorthalidone 12.5-50 mg by mouth daily for 4 weeks Chlorthalidone: Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Assessed at baseline and at 4 weeks

Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Change in 24 hour urine calcium excretion

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Assessed weekly for up to 4 weeks or until hypokalemia develops

Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Serum potassium decreased to \<3.5 milliequivalent/L

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Assessed weekly for up to 4 weeks or until hypercalcemia develops

Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Serum calcium increased to \>10.5 mg/dL

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Assessed at baseline and at 4 weeks

Population: Due to only one participant being enrolled there are concerns regarding patient confidentiality, therefore no data is being reported.

Change in serum fructosamine

Outcome measures

Outcome data not reported

Adverse Events

Chlorthalidone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carrie Dykes

University of Rochester

Phone: 15852750736

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place