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Semaglutide in CFRD

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ClinicalTrials.gov Identifier: NCT05788965
Recruitment Status : Recruiting
First Posted : March 29, 2023
Last Update Posted : June 26, 2023
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Amir Moheet, University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 15, 2023
First Posted Date  ICMJE March 29, 2023
Last Update Posted Date June 26, 2023
Actual Study Start Date  ICMJE April 30, 2023
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2023)		 Feasibility, safety, tolerability [ Time Frame: Duration of anticipated participation for an individual participant's would be around 15 weeks.Duration anticipated to complete all study procedures, including any long-term follow-up, and data analysis is 24 months. ]
The primary outcomes are related to feasibility, including safety and treatment tolerability. Safety will be evaluated as the proportion (in %) of participants who experience a serious adverse event during the study. Tolerability will be evaluated as the proportion (in %) of participants who discontinue their assigned treatment due to side effects.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Semaglutide in CFRD
Official Title  ICMJE Efficacy and Safety of GLP-1 Agonist Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
Brief Summary This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).
Detailed Description

The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. We hypothesize that weekly administration of the long-acting GLP-1RA semaglutide to overweight/obese CFRD patients will be safe and well tolerated.

Specific Aim 1: Collect pilot data on the safety and feasibility of weekly semaglutide therapy in overweight and obese patients with CFRD to support a future larger randomized controlled trial.

Hypothesis 1: Weekly therapy with GLP-1RA semaglutide will be safe and well tolerated in overweight/obese adults with CFRD.

Specific Aim 2: Collect preliminary data to examine the impact of semaglutide therapy on insulin secretion, glucagon and glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM) and HbA1c.

Hypothesis 2a: Treatment with semaglutide will lower glucose levels, and increase insulin and C-peptide area under the curve (AUC) during the OGTT as compared to baseline.

Hypothesis 2b: Treatment with semaglutide will improve glycemic control as indicated by time in range on CGM and HbA1c
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cystic Fibrosis
  • Cystic Fibrosis-related Diabetes
Intervention  ICMJE Drug: Semaglutide
glucagon-like peptide 1 (GLP-1) receptor agonist
Other Names:
  • GLP-1 RA
  • Semaglutide Injectable Product
Study Arms  ICMJE Single Arm
This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD.
Intervention: Drug: Semaglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2023)		 15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult subjects 18 years or older with CFRD and on insulin treatment
  • BMI >26 kg/m2
  • Diagnosis of pancreatic insufficiency (based on treatment with pancreatic enzyme replacement therapy)
  • A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Oral, injectable, or implanted hormonal contraceptives 3. Intrauterine device 4. Tubal ligation

Exclusion Criteria:

  • personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
  • acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
  • gastrointestinal(GI) symptom exacerbation defined by current nausea/vomiting or diarrhea at the baseline assessment
  • history of chronic GI problems requiring hospitalization in the 1 year prior to baseline
  • history of clinically symptomatic pancreatitis
  • history of clinically significant gastroparesis
  • history of eating disorders
  • less than 24 weeks since start of a new CFTR corrector/modulator therapy
  • pregnancy or lactation
  • severe CF liver disease
  • chronic kidney disease
  • history of suicide attempts or active suicidal ideation
  • Non-English speakers and those unable to read in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cathy Larson 612-625-2153 cftrials@umn.edu
Contact: Brooke Noren 612-625-7995 cftrials@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05788965
Other Study ID Numbers  ICMJE Semaglutide in CFRD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.
Current Responsible Party Amir Moheet, University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amir Moheet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Cystic Fibrosis Foundation
Investigators  ICMJE
Principal Investigator: Amir Moheet, MBBS University of Minnesota
PRS Account University of Minnesota
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP