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Treatment to Regress to Normoglycemia in Women With a Recent History of GDM (SWEET)

Primary Purpose

Pre Diabetes, Postpartum Disorder

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Semaglutide Pen Injector [Ozempic]

Placebo semaglutide pen injector

About this trial

This is an interventional treatment trial for Pre Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Female
18 - 45 years old (inclusive)
History of gestational diabetes in most recent pregnancy
6 - 36 months postpartum
BMI ≥ 25 kg/m2
Use of long-acting reversible contraception or bilateral tubal ligation
Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):
1. Fasting glucose 100-125mg/dL (inclusive) and/or
2. 120 minute glucose 140-199mg/dL (inclusive)
Willingness to maintain physical activity level throughout study duration
Willingness to standardize diet for 3 days prior to OGTT
Ability to provide informed consent before any trial-related activities

Exclusion Criteria:

Body weight > 350lb
Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures.
Breastfeeding within 3 months of screening visit 1
Post-menopausal
Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
Use of tobacco products within past 6 months
Substance or alcohol abuse
Presence of significant systemic disease including: diabetes mellitus (type 1 or type 2), cardiac disease (e.g. congestive heart failure), renal impairment (e.g. serum creatinine levels ≥ 1.4 mg/dL or eGFR < 60), hepatic disease (including viral hepatitis, toxic hepatic damage, jaundice of unknown aetiology, or abnormal liver function tests), pancreatitis, uncontrolled thyroid disease (e.g. documented abnormal TSH), adrenal disease (including Cushing's syndrome, congenital adrenal hyperplasia), hyperlipidemia (fasting triglycerides > 399mg%), untreated or poorly controlled hypertension (resting blood pressure >159/94 mmHg)
History of or presence of: eating disorder, malignant disease requiring chemotherapy, or debilitating psychiatric disorder such as psychosis or neurological condition that could confound outcome variables
History of bariatric surgery
Use of medications for glucose regulation: insulin (e.g. Humalog, Novolog, Humulin), pramlintide, metiglinides, metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors within four weeks of screening visit 1
Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
Known or suspected allergy to trial medication, excipients, or related products
Contraindications to study medications: patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Current or recent past (within 3 months) participation in another experimental drug trial
Previous randomization in this trial
Receipt of any investigational drug within 6 months prior to this trial

Sites / Locations

Woman's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Semaglutide Pen Injector (Ozempic)

Placebo

Arm Description

Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week)

Weekly injections of placebo for 8 months total

Outcomes

Primary Outcome Measures

Regression to normoglycemia

Glucose tolerance to be determined by glycemic response to a 75 gram, two-hour oral glucose tolerance test (OGTT). Regression to normoglycemia is defined by fasting glucose <100mg/dL and 120 minute glucose <140 mg/dL

Secondary Outcome Measures

Change in HbA1c

Hemoglobin to be determined

Change in body weight

Fasted body weight after intervention minus fasted body weight at enrollment

Full Information

NCT ID

NCT04873050

First Posted

April 29, 2021

Last Updated

April 24, 2023

Sponsor

Woman's

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04873050

Brief Title

Treatment to Regress to Normoglycemia in Women With a Recent History of GDM

Acronym

SWEET

Official Title

A Randomized, Placebo-controlled, Double Blind Trial of Semaglutide 1mg (Ozempic®) on Regression to Normoglycemia in WomEn With a Recent History of Gestational diabETes Mellitus: The SWEET Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 13, 2022 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Woman's

Collaborators

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to determine the efficacy of semaglutide 1mg (Ozempic®) to aid recently postpartum women with dysglycemia and a history of GDM to regress to normoglycemia; thereby filling a gap in efficacious pharmacologic intervention options for clinicians to support postpartum diabetes recovery and reduce future risk of T2DM in young women.

Detailed Description

The diagnosis of gestational diabetes mellitus (GDM) during pregnancy identifies young women with abnormalities in pancreatic beta cell function that worsen over time, leading to diabetes. It is estimated that between 15% and 70% of women with a history GDM will progress to type 2 diabetes mellitus (T2DM). However, upon an impaired glucose tolerance test result in the early postpartum period, the American College of Obstetricians and Gynecologists only recommend considering referral for management, weight loss and physical activity counseling, considering metformin if testing results are severe enough, and yearly assessment of glycemic status. In many cases, it is possible to reverse diabetes by losing weight in the early stages before permanent, systemic damage occurs. Therefore, there is a dire need for efficacious pharmacologic intervention options in this period of postpartum diabetes recovery to return women to normoglycemia and lower future T2DM risk. Weight loss and medications that mitigate impairments in insulin secretion show the best promise for delaying or preventing T2DM, the dominant form of diabetes that develops after GDM. The primary study objective is "to examine the efficacy of semaglutide 1mg compared to placebo on regression to normoglycemia in women with dysglycemia and a recent history of gestational diabetes mellitus (i.e., 6-36 months postpartum)" to answer the research question of: "Among women with dysglycemia and a recent history of gestational diabetes mellitus, can acute treatment of semaglutide 1mg lead to regression to normoglycemia?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre Diabetes, Postpartum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide Pen Injector (Ozempic)

Arm Type

Experimental

Arm Description

Weekly injections of semaglutide for 8 months total (2 months of titration; 6 months of full dose- 1mg/week)

Arm Title

Placebo

Arm Type

Sham Comparator

Arm Description

Weekly injections of placebo for 8 months total

Intervention Type

Drug

Intervention Name(s)

Semaglutide Pen Injector [Ozempic]

Other Intervention Name(s)

Semaglutide 1mg, Ozempic

Intervention Description

Start injection of semaglutide 0.25mg subcutaneously (SC) once a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses

Intervention Type

Drug

Intervention Name(s)

Placebo semaglutide pen injector

Other Intervention Name(s)

Placebo Semaglutide 1mg, Placebo Ozempic

Intervention Description

Start injection of placebo semaglutide 0.25mg subcutaneously (SC) one a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses

Primary Outcome Measure Information:

Title

Regression to normoglycemia

Description

Time Frame

After 24 weeks of full-dose treatment

Secondary Outcome Measure Information:

Title

Change in HbA1c

Description

Hemoglobin to be determined

Time Frame

After 24 weeks of full-dose treatment

Title

Change in body weight

Description

Fasted body weight after intervention minus fasted body weight at enrollment

Time Frame

After 24 weeks of full-dose treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female 18 - 45 years old (inclusive) History of gestational diabetes in most recent pregnancy 6 - 36 months postpartum BMI ≥ 25 kg/m2 Use of long-acting reversible contraception or bilateral tubal ligation Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT): Fasting glucose 100-125mg/dL (inclusive) and/or 120 minute glucose 140-199mg/dL (inclusive) Willingness to maintain physical activity level throughout study duration Willingness to standardize diet for 3 days prior to OGTT Ability to provide informed consent before any trial-related activities Exclusion Criteria: Body weight > 350lb Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures. Breastfeeding within 3 months of screening visit 1 Post-menopausal Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment) Use of tobacco products within past 6 months Substance or alcohol abuse Presence of significant systemic disease including: diabetes mellitus (type 1 or type 2), cardiac disease (e.g. congestive heart failure), renal impairment (e.g. serum creatinine levels ≥ 1.4 mg/dL or eGFR < 60), hepatic disease (including viral hepatitis, toxic hepatic damage, jaundice of unknown aetiology, or abnormal liver function tests), pancreatitis, uncontrolled thyroid disease (e.g. documented abnormal TSH), adrenal disease (including Cushing's syndrome, congenital adrenal hyperplasia), hyperlipidemia (fasting triglycerides > 399mg%), untreated or poorly controlled hypertension (resting blood pressure >159/94 mmHg) History of or presence of: eating disorder, malignant disease requiring chemotherapy, or debilitating psychiatric disorder such as psychosis or neurological condition that could confound outcome variables History of bariatric surgery Use of medications for glucose regulation: insulin (e.g. Humalog, Novolog, Humulin), pramlintide, metiglinides, metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors within four weeks of screening visit 1 Use of medications for anti-obesity or weight loss within four weeks of screening visit 1 Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1 Known or suspected allergy to trial medication, excipients, or related products Contraindications to study medications: patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Current or recent past (within 3 months) participation in another experimental drug trial Previous randomization in this trial Receipt of any investigational drug within 6 months prior to this trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Donna Shaler, BS

Phone

225-231-5268

Donna.Shaler@womans.org

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Elkind-Hirsch, PhD

Phone

2259245278

karen.elkind-hirsch@womans.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Sutton, PhD

Organizational Affiliation

Woman's Hospital, Louisiana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Woman's Hospital

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth Sutton, PhD

Phone

225-924-8446

elizabeth.sutton@womans.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment to Regress to Normoglycemia in Women With a Recent History of GDM

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