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Trial Outcomes & Findings for Treatment of GLP-1 for Diabetic Bariatric Patients (NCT NCT04624672)

NCT ID: NCT04624672

Last Updated: 2023-11-14

Results Overview

HbA1C \< 6.5%, fasting glucose \<125 mg/dl, or no medications or active treatment for one year

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

11 months

Results posted on

2023-11-14

Participant Flow

Participant milestones

Participant milestones
Measure
Control Arm
Once weekly injection of placebo 4-6 months at prescribed dose Placebo: Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Test Arm
Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose Semaglutide (1 Mg Dose): Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery
Overall Study
STARTED
2
1
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Control Arm
Once weekly injection of placebo 4-6 months at prescribed dose Placebo: Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
Test Arm
Once weekly injection of 1.0mg Semaglutide 4-6 months at prescribed dose Semaglutide (1 Mg Dose): Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery
Overall Study
Early Study Closure
2
1

Baseline Characteristics

Treatment of GLP-1 for Diabetic Bariatric Patients

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 11 months

Population: Due to low recruitment numbers (\>5), no data analysis was completed because total number of patients recruited is too low to ensure patient confidentiality.

HbA1C \< 6.5%, fasting glucose \<125 mg/dl, or no medications or active treatment for one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 11 months

Population: Due to low recruitment numbers (\>5), no data analysis was completed because total number of patients recruited is too low to ensure patient confidentiality.

HbA1C \< 6.0%, fasting glucose \<100 mg/dl, or no medications or active treatment for o

Outcome measures

Outcome data not reported

Adverse Events

Control Arm

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

Test Arm

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

Project Manager

Geisinger Medical Center

Phone: 570-214-2245

Results disclosure agreements

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