Diabetes Prevention in Women After GDM Who Are at High-riskPhase 3DAPA-GDMNCT02338193
Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women
A Phase 3 study testing DAPA/MET XR, DAPA and MET XR in people with Diabetes Prevention in Women After GDM Who Are at High-risk, run by Woman's at 1 site in United States.
Trial summary
Women with a history of gestational diabetes (GDM) are at substantially increased risk of type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more likely to be overweight or obese. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention in Women After GDM Who Are at High-risk
- What is being tested?
- DAPA/MET XR, DAPA and MET XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2015to 13 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Overweight/obese (BMI >25) females 18 years to 45 years of age, who experienced gestational diabetes (GDM) during recent (within 12 months) pregnancy
- postpartum metabolic abnormalities determined by a 75 g oral glucose tolerance test (Inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum)
- Completed lactation
- Using adequate contraception during study period unless sterilized
- Written consent for participation in the study
Who cannot join
- Cholestasis during the past pregnancy
- Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology), gallstones, abnormal liver function tests or renal impairment (elevated serum creatinine levels or abnormal creatinine clearance
- Presence of significant systemic disease, heart problems including congestive heart failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2)
- Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR <60)
- Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %)
- Untreated or poorly controlled hypertension (sitting blood pressure >160/95mm Hg)
Show all 22Show fewer
- Prior history of a malignant disease requiring chemotherapy
- Known hypersensitivity or contraindications to use of insulin sensitizers such as metformin or thiazolidinediones
- History of hypersensitivity reaction to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions)
- Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors or weight loss medications (prescription or OTC)
- Uncontrolled thyroid disease (documented normal TSH) or hyperprolactinemia
- Liver enzymes (serum alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] ) levels exceeding more than twice normal lab values
- Use of drugs known to exacerbate glucose tolerance
- History of diabetes or prior use of medications to treat diabetes except GDM
- Currently lactating
- Eating disorders (anorexia, bulimia) or gastrointestinal disorders
- Suspected pregnancy (documented negative serum pregnancy test within 72 hours before first dose of study drug), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months
- Active or prior history of substance abuse (smoke or tobacco use within past 3 years) or significant intake of alcohol or history of alcoholism
- Patient not willing to use adequate contraception during study period and up to 4 weeks after last dose of study drug (unless sterilized).
- Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables
- Inability or refusal to comply with protocol
- Not currently participating or having participated in an experimental drug study in previous three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study Evaluating Dapagliflozin and Metformin, Alone and in Combination, in Overweight Women With a Recent History of Gestational Diabetes Mellitus: Effects on Anthropometric Measurements and Cardiometabolic Abnormalities
Women with a history of gestational diabetes (GDM) are at substantially increased risk of type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated with T2DM, independent of baseline body weight. Weight gain, particularly increased central adiposity after delivery, is strongly associated with deterioration of β-cell compensation for insulin resistance. Taken together, our findings and other studies support increased abdominal fat as the strongest factor associated with declining B-cell compensation for insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin is a novel highly selective SGLT2 inhibitor that improves glycemic control by reducing renal glucose reabsorption leading to urinary glucose excretion. Its efficacy and safety has been studied in multiple randomized controlled trials including an add-on to metformin compared with a placebo. To the extent that glucotoxicity contributes to the demise in β-cell function in subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the treatment of "prediabetes." An additional secondary benefit of SGLT2 inhibition is the elimination of calories in the form of glucose. The loss of glucose with attendant caloric loss contributes to weight loss; in addition, improvements in β cell function have been seen. Weight loss seen with SGLT2 inhibitors is similar to that seen with glucagon-like peptide 1 analogs, and may be more acceptable because they are oral agents. A consistent finding in all dapagliflozin studies has been a reduction in blood pressure. The investigators hypothesize that combination dapagliflozin -metformin treatment over a 24-week period will have a greater positive impact on body weight, anthropometric measurements and glycemic and cardiometabolic parameters than dapagliflozin or metformin monotherapy in overweight/obese at-risk women with a history of GDM.
Read the detailed description
Following written consent, all study patients will undergo the following clinical, metabolic and laboratory evaluations before and during treatment. To ensure that patients remain unidentified, all study subjects will be assigned an individual study identifier which includes the study acronym, patient initials, and unique number. All blood samples will be obtained and results identified and reported using this unique study identifier. A full physical examination will be performed and vital signs (blood pressure, respiration and temperature) determined. Trained personnel using standardized protocols at the baseline and follow-up examination will obtain anthropometric measurements and blood specimens. Absolute body weight, height, waist and hip circumference, body fat distribution (waist/hip {WHR}) and waist/height ratio ({WHtR}) and blood pressure (BP) will be determined. Body weight will be measured to the nearest 0.1 kg using a calibrated digital scale with participants in light clothing and no shoes. Height will be measured to the nearest centimeter. The total body adiposity (total fatness), defined as the accumulation of body fat without regard to regional distribution, will be expressed as BMI and calculated as weight (kg)/ height (m) 2. The circumference measurements will be taken in the upright position using a 15-mm width flexible metric tape held close to the body but not tight enough to indent the skin. Waist circumference (WC) will be measured at the narrowest level midway between the lowest ribs and the iliac crest and hip circumference measured at the widest level over the buttocks while the subjects are standing and breathing normally. The WHR and WHtR will be calculated for measure of body fat distribution.
All patients will randomly be assigned to one of 3 medication treatment groups-- dapagliflozin-metformin (DAP-MET; 5 mg DAP/ MET 1000 mg BID), metformin XR (MET 1000 mg BID) or dapagliflozin (DAP 10 mg QD); all subjects will be allocated to one of these 3 groups based on computer-generated random numbers using a block randomization method. Oral glucose tolerance tests (OGTTs) with glucose (G) and insulin (I) measured at 0, 30, 60, and 120 after glucose load to assess diabetes, fasting (FBG) and mean blood glucose (MBG) concentrations, insulin resistance and pancreatic ß-cell function will be performed prior to randomization and at 20-24 weeks after full doses of study medications are reached. Mean blood glucose (MBG) concentrations will be calculated by summing glucose values obtained at 0,30,60 and 120 minutes during the OGTT and dividing by 4. At the initial lab evaluation, creatinine and calculated eGFR, TSH, and ß-hCG will be determined for study inclusion. Baseline blood samples will also be analyzed for lipid profiles and liver enzymes.
All patients will receive the same counseling concerning the benefits of lifestyle modification through diet and exercise. The patients will be also encouraged to increase daily exercise (such as walking, using stairs), although this will not be formally assessed. The participants will receive further encouragement to adhere to the regime during follow-up phone calls. Side effects of the treatment and reason for any withdrawals from the study will be recorded.
- Being tested
- DAPA/MET XR, DAPA, MET XR
- Keywords
- GDM, T2DM, prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPA/MET XRDrug
Also called Xigduo 5mg/1000 mg
final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
DAPADrug
Also called Farxiga 10 mg
10 mg dapagliflozin QD for 20-24 weeks
MET XRDrug
Also called Glucophage XR 500 mg
1000 mg Metformin XR BID for 20-24 weeks
| Study group | Role | What they receive |
|---|---|---|
| DAPA/MET Extended Release (XR) | Experimental | Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks Receives: Drug: DAPA/MET XR |
| Dapaglifloxin | Active comparator | Dapagliflozin- 10 mg once daily before first meal for 24 weeks Receives: Drug: DAPA |
| Metformin XR | Active comparator | Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the morning (AM), 1000 mg in the evening ( PM) for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks Receives: Drug: MET XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24
Measured: Change from baseline (time 0) to study end (24 weeks)
Secondary outcomes (15)
Change in Percent Body Weight
Change in percent body weight with combination therapy compared to monotherapy from baseline to week 24
Measured: Change from baseline (time 0) to study end (24 weeks)
Body Mass Index (BMI)
BMI (measure of overall adiposity) in combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Waist Circumference (WC)
Waist size (measure of truncal adiposity)with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Waist- to -Hip Ratio (WHR; Measure of Central Adiposity)
Waist-to-hip ratio with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Waist-to-height Ratio (WHtR)
Waist divided by height a( measure of central adiposity) with combination therapy compared to monotherapy after 24 weeks of therapy
Measured: 24 weeks of treatment
Diastolic Blood Pressure (DBP)
Diastolic blood pressure with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment)
Systolic Blood Pressure (SBP)
Systolic blood pressure with combination therapy compared to monotherapy after 24 weeks of therapy
Measured: 24 weeks of treatment
Liver Enzymes
ALT/AST ratio with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Total Cholesterol Levels (CHOL)
Cholesterol levels with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Triglyceride (TRG) Levels
Triglyceride levels with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Fasting Blood Glucose (FBG)
Fasting blood glucose levels with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Mean Blood Glucose (MBG) During an OGTT
Mean blood glucose after glucose load with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Fasting Insulin Sensitivity (HOMA-IR)
HOMA index of insulin resistance calculated from fasting insulin and glucose with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Matsuda Sensitivity Index (SI OGTT)
Surrogate measure of insulin sensitivity derived from OGTT with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
First Phase Insulin Secretion (IGI/HOMA-IR)
Corrected early insulin response to glucose challenge [(insulinogenic index (IGI)/ divided by fasting insulin resistance index (HOMA-IR)] with combination therapy compared to monotherapy after 24 weeks of treatment
Measured: 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study start22 Sep 2015
- Primary completion13 Feb 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Prevention in Women After GDM Who Are at High-riskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Karen Elkind-Hirsch, Woman's
- Investigators
- Karen E Elkind-Hirsch, PhD, Principal investigator, Woman's Hospital, LouisianaRenee Harris, MD, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338193
- Sponsor's protocol ID
- RP-14-012
- Acronym
- DAPA-GDM
- Status last verified
- Jun 2019
- First submitted
- 7 Jan 2015
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Will publish findings. Individual patient information will be revealed only to patient
Publications
Elkind-Hirsch KE, Seidemann E, Harris R. A randomized trial of dapagliflozin and metformin, alone and combined, in overweight women after gestational diabetes mellitus. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100139. doi: 10.1016/j.ajogmf.2020.100139. Epub 2020 May 16.
PubMed 33345876
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating Dapagliflozin and Metformin, Alone and in Combination, in Overweight Women With a Recent History of Gestational Diabetes Mellitus: Effects on Anthropometric Measurements and Cardiometabolic Abnormalities
- ClinicalTrials.gov ID
- NCT02338193
- Acronym / sponsor ID
- DAPA-GDM / RP-14-012
- Keywords
- GDM, T2DM, prediabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Posted 30 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with a history of gestational diabetes (GDM) are at substantially increased risk of type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated with T2DM, independent of baseline body weight. Weight gain, particularly increased central adiposity after delivery, is strongly associated with deterioration of β-cell compensation for insulin resistance. Taken together, our findings and other studies support increased abdominal fat as the strongest factor associated with declining B-cell compensation for insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin is a novel highly selective SGLT2 inhibitor that improves glycemic control by reducing renal glucose reabsorption leading to urinary glucose excretion. Its efficacy and safety has been studied in multiple randomized controlled trials including an add-on to metformin compared with a placebo. To the extent that glucotoxicity contributes to the demise in β-cell function in subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the treatment of "prediabetes." An additional secondary benefit of SGLT2 inhibition is the elimination of calories in the form of glucose. The loss of glucose with attendant caloric loss contributes to weight loss; in addition, improvements in β cell function have been seen. Weight loss seen with SGLT2 inhibitors is similar to that seen with glucagon-like peptide 1 analogs, and may be more acceptable because they are oral agents. A consistent finding in all dapagliflozin studies has been a reduction in blood pressure. The investigators hypothesize that combination dapagliflozin -metformin treatment over a 24-week period will have a greater positive impact on body weight, anthropometric measurements and glycemic and cardiometabolic parameters than dapagliflozin or metformin monotherapy in overweight/obese at-risk women with a history of GDM.
Detailed description
Following written consent, all study patients will undergo the following clinical, metabolic and laboratory evaluations before and during treatment. To ensure that patients remain unidentified, all study subjects will be assigned an individual study identifier which includes the study acronym, patient initials, and unique number. All blood samples will be obtained and results identified and reported using this unique study identifier. A full physical examination will be performed and vital signs (blood pressure, respiration and temperature) determined. Trained personnel using standardized protocols at the baseline and follow-up examination will obtain anthropometric measurements and blood specimens. Absolute body weight, height, waist and hip circumference, body fat distribution (waist/hip {WHR}) and waist/height ratio ({WHtR}) and blood pressure (BP) will be determined. Body weight will be measured to the nearest 0.1 kg using a calibrated digital scale with participants in light clothing and no shoes. Height will be measured to the nearest centimeter. The total body adiposity (total fatness), defined as the accumulation of body fat without regard to regional distribution, will be expressed as BMI and calculated as weight (kg)/ height (m) 2. The circumference measurements will be taken in the upright position using a 15-mm width flexible metric tape held close to the body but not tight enough to indent the skin. Waist circumference (WC) will be measured at the narrowest level midway between the lowest ribs and the iliac crest and hip circumference measured at the widest level over the buttocks while the subjects are standing and breathing normally. The WHR and WHtR will be calculated for measure of body fat distribution.
All patients will randomly be assigned to one of 3 medication treatment groups-- dapagliflozin-metformin (DAP-MET; 5 mg DAP/ MET 1000 mg BID), metformin XR (MET 1000 mg BID) or dapagliflozin (DAP 10 mg QD); all subjects will be allocated to one of these 3 groups based on computer-generated random numbers using a block randomization method. Oral glucose tolerance tests (OGTTs) with glucose (G) and insulin (I) measured at 0, 30, 60, and 120 after glucose load to assess diabetes, fasting (FBG) and mean blood glucose (MBG) concentrations, insulin resistance and pancreatic ß-cell function will be performed prior to randomization and at 20-24 weeks after full doses of study medications are reached. Mean blood glucose (MBG) concentrations will be calculated by summing glucose values obtained at 0,30,60 and 120 minutes during the OGTT and dividing by 4. At the initial lab evaluation, creatinine and calculated eGFR, TSH, and ß-hCG will be determined for study inclusion. Baseline blood samples will also be analyzed for lipid profiles and liver enzymes.
All patients will receive the same counseling concerning the benefits of lifestyle modification through diet and exercise. The patients will be also encouraged to increase daily exercise (such as walking, using stairs), although this will not be formally assessed. The participants will receive further encouragement to adhere to the regime during follow-up phone calls. Side effects of the treatment and reason for any withdrawals from the study will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DAPA/MET Extended Release (XR) | Experimental | Drug: DAPA/MET XRDapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks |
| Dapaglifloxin | Active comparator | Drug: DAPADapagliflozin- 10 mg once daily before first meal for 24 weeks |
| Metformin XR | Active comparator | Drug: MET XRMetformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the morning (AM), 1000 mg in the evening ( PM) for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Overweight/obese (BMI >25) females 18 years to 45 years of age, who experienced gestational diabetes (GDM) during recent (within 12 months) pregnancy
Key exclusion criteria (22 listed)
- Cholestasis during the past pregnancy
- Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology), gallstones, abnormal liver function tests or renal impairment (elevated serum creatinine levels or abnormal creatinine clearance
- Presence of significant systemic disease, heart problems including congestive heart failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2)
- Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR <60)
- Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAPA/MET XRAlso: Xigduo 5mg/1000 mgfinal dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks | Drug | DAPA/MET Extended Release (XR) |
| DAPAAlso: Farxiga 10 mg10 mg dapagliflozin QD for 20-24 weeks | Drug | Dapaglifloxin |
| MET XRAlso: Glucophage XR 500 mg1000 mg Metformin XR BID for 20-24 weeks | Drug | Metformin XR |
Primary outcome
Change in Body Weight
Time frame: Change from baseline (time 0) to study end (24 weeks)
Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24
15 secondary outcomes
Change in Percent Body Weight
Time frame: Change from baseline (time 0) to study end (24 weeks)
Body Mass Index (BMI)
Time frame: 24 weeks of treatment
Waist Circumference (WC)
Time frame: 24 weeks of treatment
Waist- to -Hip Ratio (WHR; Measure of Central Adiposity)
Time frame: 24 weeks of treatment
Waist-to-height Ratio (WHtR)
Time frame: 24 weeks of treatment
Diastolic Blood Pressure (DBP)
Time frame: 24 weeks of treatment)
Systolic Blood Pressure (SBP)
Time frame: 24 weeks of treatment
Liver Enzymes
Time frame: 24 weeks of treatment
Total Cholesterol Levels (CHOL)
Time frame: 24 weeks of treatment
Triglyceride (TRG) Levels
Time frame: 24 weeks of treatment
Fasting Blood Glucose (FBG)
Time frame: 24 weeks of treatment
Mean Blood Glucose (MBG) During an OGTT
Time frame: 24 weeks of treatment
Fasting Insulin Sensitivity (HOMA-IR)
Time frame: 24 weeks of treatment
Matsuda Sensitivity Index (SI OGTT)
Time frame: 24 weeks of treatment
First Phase Insulin Secretion (IGI/HOMA-IR)
Time frame: 24 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33345876Elkind-Hirsch KE, Seidemann E, Harris R. A randomized trial of dapagliflozin and metformin, alone and combined, in overweight women after gestational diabetes mellitus. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100139. doi: 10.1016/j.ajogmf.2020.100139. Epub 2020 May 16.
- Individual participant dataSharing planned: No. Will publish findings. Individual patient information will be revealed only to patient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen E Elkind-Hirsch, PhD principal investigator
Woman's Hospital, Louisiana
Renee Harris, MD principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DAPA/MET XR, DAPA and MET XR in people with Diabetes Prevention in Women After GDM Who Are at High-risk, run by Woman's at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Change from baseline (time 0) to study end (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02338193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.