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Trial Outcomes & Findings for Central Mechanisms That Regulate Glucose Metabolism in Humans (NCT NCT01028846)

NCT ID: NCT01028846

Last Updated: 2025-05-16

Results Overview

Rate of EGP (a measure of the body's production of sugar) was measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., diazoxide or placebo) by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Rates were summarized by treatment (Diazoxide or Placebo) in mg/kg/min sing basic descriptive statistics.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Final 60 minutes (t=180-240 minutes) of the pancreatic clamp, 6-7 hours after dosing

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure
Diazoxide Followed by Placebo
Participants were initially administered 4 mg/kg body weight total dosage of diazoxide orally followed by saline orally after a two-week washout period. Diazoxide: 4 mg/kg body weight total dosage administered orally. Placebo: Oral saline
Placebo Followed by Diazoxide
Participants were initially administered saline orally followed by 4 mg/kg body weight total dosage of diazoxide orally after a two-week washout period. Placebo: Oral saline Diazoxide: 4 mg/kg body weight total dosage administered orally
1st Intervention
STARTED
5
5
1st Intervention
COMPLETED
5
5
1st Intervention
NOT COMPLETED
0
0
Washout (~1 Month)
STARTED
5
5
Washout (~1 Month)
COMPLETED
5
5
Washout (~1 Month)
NOT COMPLETED
0
0
2nd Intervention
STARTED
5
5
2nd Intervention
COMPLETED
5
5
2nd Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=10 Participants
Participants were administered 4 mg/kg body weight total dosage of diazoxide orally followed by saline orally after a two-week washout period. Diazoxide: 4 mg/kg body weight total dosage administered orally. Placebo: Oral saline
Age, Categorical
<=18 years
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=10 Participants
Age, Categorical
>=65 years
0 Participants
n=10 Participants
Age, Continuous
33.0 years
STANDARD_DEVIATION 2.5 • n=10 Participants
Sex: Female, Male
Female
3 Participants
n=10 Participants
Sex: Female, Male
Male
7 Participants
n=10 Participants
Region of Enrollment
United States
10 participants
n=10 Participants
Body Mass Index (BMI)
27.4 kg/m^2
STANDARD_DEVIATION 1.5 • n=10 Participants

PRIMARY outcome

Timeframe: Final 60 minutes (t=180-240 minutes) of the pancreatic clamp, 6-7 hours after dosing

Rate of EGP (a measure of the body's production of sugar) was measured using analysis of blood samples taken throughout the pancreatic clamp procedure under various treatment conditions (e.g., diazoxide or placebo) by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). Rates were summarized by treatment (Diazoxide or Placebo) in mg/kg/min sing basic descriptive statistics.

Outcome measures

Outcome measures
Measure
Diazoxide
n=10 Participants
Participants were administered 4 mg/kg body weight total dosage of diazoxide. Diazoxide: 4 mg/kg body weight total dosage administered orally.
Placebo
n=10 Participants
Participants were administered saline orally. Placebo: Oral saline
Rate of Endogenous Glucose Production (EGP)
1.15 mg/kg/min
Standard Error 0.13
1.63 mg/kg/min
Standard Error 0.17

Adverse Events

Diazoxide

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Diazoxide
n=10 participants at risk
Participants were administered 4 mg/kg body weight total dosage of diazoxide. Diazoxide: 4 mg/kg body weight total dosage administered orally.
Placebo
n=10 participants at risk
Participants were administered saline orally. Placebo: Oral saline
Metabolism and nutrition disorders
Mild Hypoglycemia (Asymptomatic)
10.0%
1/10 • Patients were assessed for up to 8 hours during two separate visits approximately 1 month apart.
0.00%
0/10 • Patients were assessed for up to 8 hours during two separate visits approximately 1 month apart.

Additional Information

Dr. Meredith Hawkins

Albert Einstein College of Medicine

Phone: 718-839-7975

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place