Gestational Diabetes MellitusPhase 3NCT01234649
Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)
A Phase 3 study testing Metformin XR plus liraglutide in people with Gestational Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Woman's at 1 site in United States.
Trial summary
A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. 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
- Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus, Metabolic Syndrome
- What is being tested?
- Metformin XR plus liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2011to 14 Jun 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
- Adult female 18 years to 45 years of age who experienced GDM within 52 weeks of index pregnancy
- Actual BMI >25 kg/ m2
- Written consent for participation in the study
- Patient completed lactation
- Dysglycemia (impaired fasting glucose [IFG}, impaired glucose tolerance [IGT} or IFG/IGT) and/or ß-cell dysfunction postpartum requiring pharmacological intervention (except type 1 or 2 diabetes)
Who cannot join
- Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
- History of pancreatitis
- Significant cardiovascular, cerebrovascular, renal, or hepatobiliary diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)
- Serum liver enzymes (AST and/or ALT levels) exceeding more than twice normal laboratory values
- Uncontrolled hypertension (systolic blood pressure>150 mm Hg and/or diastolic blood pressure >90 mm Hg)
- Fasting serum triglycerides ≥800 mg/dl at screening. Lipid-lowering medications must have been maintained at the same dose for 3 months prior to enrollment
Show all 18Show fewer
- Hematological profiles considered to be clinically significant
- Cholestasis during the past pregnancy
- Presence of contradictions for GLP-1 receptor agonist or metformin administration such as allergy or hypersensitivity
- Current use of metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors or GLP-1 receptor agonist medications.
- Use of drugs known to exacerbate glucose tolerance.
- Use of prescription or over-the-counter weight-loss drugs
- Diabetes postpartum or history of diabetes or prior use of medications to treat diabetes except gestational diabetes
- Creatinine clearance less than 60 ml/min
- History or currently undergoing chemotherapy or radiotherapy for cancer
- Pregnancy planned during the coming two years
- Currently breastfeeding
- Exclusion criteria include any condition, which in the opinion of the investigator would place the subject at increased risk or otherwise make the subject unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intervention With the Glucagon-like Peptide 1 (GLP-1) Analog Liraglutide Plus Metformin Versus Metformin Monotherapy in Overweight/Obese Women With Metabolic Defects and Recent History of Gestational Diabetes Mellitus (GDM)
A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with prior GDM.
Read the detailed description
Gestational diabetes is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. . Despite the high and increasing rate of type 2 diabetes in Louisiana, the medical community does not have reliable estimates of the number of woman living in southern Louisiana who develop diabetes subsequent to GDM. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater than control groups who did not have glucose intolerance during pregnancy. The higher rates were in studies of particular ethnic groups in the U.S. Recently, follow-up programs elsewhere also have identified increasing rates of type 2 diabetes by 5-10 years after GDM: 9-43% type 2 diabetes in Europe and 11-21% in Asia. The frequency of type 2 diabetes is influenced by BMI, weight gain after pregnancy, family history of diabetes, fasting and postchallenge glucose levels during and after pregnancy, postpartum insulin resistance and inadequate β-cell secretion, and the need for pharmacological treatment during pregnancy. However, the risk factors are unable to predict all cases of subsequent type 2 diabetes: the biggest risk factor is a GDM pregnancy. Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, lifestyle modification and pharmacological therapies. Lifestyle intervention was found to reduce the incidence of type 2 diabetes by 58% and metformin by 31% as compared with placebo. The use of rosiglitazone in subjects with prediabetes resulted in a 60% reduction of the diabetes incidence rate. Studies are needed for optimal postpartum and long-term health of women who have had GDM. Considerable recent evidence suggests that incretin-based therapies may be useful for the treatment of DM2 because continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial improvements in glucose control and ß-cell function in subjects with type 2 diabetes. Infusion of GLP-1 improves first and second-phase insulin secretion suggesting that early GLP-1 therapy may preserve ß-cell function in subjects with IGT or mild DM2. Whereas native GLP-1 has a very short half-life, the GLP-1 analogue liraglutide has a prolonged action (t1/2=13 h) suitable for once-daily injection. Liraglutide may potentially delay disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving metabolic parameters in at-risk overweight/obese women with prior GDM
- Conditions
- Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus, Metabolic Syndrome, Impaired Glucose Tolerance, Disorder of Glucose Regulation
- Being tested
- Metformin XR plus placebo, Metformin XR plus liraglutide
- Keywords
- gestational diabetes mellitus, type 2 diabetes mellitus, metabolic dysfunction, impaired fasting glucose, impaired glucose tolerance, incretin mimetic
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Metabolic Syndrome, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin XR plus placeboDrug
Also called Metformin XR is generic
Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated
Metformin XR plus liraglutideDrug
Also called Victoza
Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)
| Study group | Role | What they receive |
|---|---|---|
| Metformin XR plus liraglutide | Experimental | Metformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated Receives: Drug: Metformin XR plus liraglutide |
| Metformin XR plus placebo | Active comparator | Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated Receives: Drug: Metformin XR plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion-Sensitivity Index (IS-SI)
IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET)
Measured: 84 weeks of treatment
Secondary outcomes (21)
Fasting Blood Glucose (FBG)
Fasting glucose levels in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Mean Glucose During OGTT (MBG)
MBG derived from average glucose measured during OGTT in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR, a measure of insulin resistance derived from fasting values, in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Matsuda Insulin Sensitivity Index Derived From OGTT
OGTT- derived insulin sensitivity index in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Insulinogenic Index (IGI) /HOMA-IR
IGI/HOMA-IR, a measure of early insulin response corrected by fasting insulin resistance, in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Absolute Body Weight
Body weight in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)
Change in body weight from baseline to end o f study in LIRA-MET group compared with PL-MET group. The number was derived from final weight minus baseline and normalized to a percent.
Measured: Change from baseline (time 0) to study end (84 weeks)
Body Mass Index (BMI)
BMI, a measure of total body adiposity, in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Waist Circumference (WC)
Waist size (measure of truncal adiposity) with LIRA-MET compared to PL-MET
Measured: 84 weeks of treatment
Waist-to-Hip Ratio (WHR)
Waist circumference divided by hip circumference (a measure of central adiposity) in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Waist to Height Ratio (WHtR)
Waist circumference divided by height (measure of body fat distribution) in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Total Cholesterol (CHOL) Levels
CHOL levels in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
High Density Lipoprotein Cholesterol (HDL-C) Levels
HDL-C levels in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Low Density Lipoprotein Cholesterol (LDL-C) Levels
LDL-Cholesterol levels in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Triglyceride (TRG) Levels
TRG concentrations in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)
TRG/HDL-Cholesterol levels in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Systolic Blood Pressure
SBP in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Diastolic Blood Pressure
DBP in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Alanine Aminotransferase (ALT) Levels
Hepatic enzyme, ALT, associated with insulin resistance, in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Aspartate Aminotransferase (AST)
The hepatic marker, AST, associated with insulin resistance in LIRA-MET group compared with PL-MET group
Measured: 84 weeks of treatment
Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio
ALT/AST ratio, used to assess liver function in LIRA-MET group compared with PL-MET group
Measured: 84 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 posted4 Nov 2010 (estimated)
- Study start11 Aug 2011
- Primary completion24 Apr 2019
- Study completion14 Jun 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 Gestational Diabetes MellitusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Karen Elkind-Hirsch, Woman's
- Investigators
- Karen E Elkind-Hirsch, Ph.D., Principal investigator, Woman's Hospital, LouisianaRenee Harris, M.D., Study director, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234649
- Sponsor's protocol ID
- RP10-012
- Status last verified
- Jul 2019
- First submitted
- 3 Nov 2010
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Elkind-Hirsch KE, Shaler D, Harris R. Postpartum treatment with liraglutide in combination with metformin versus metformin monotherapy to improve metabolic status and reduce body weight in overweight/obese women with recent gestational diabetes: A double-blind, randomized, placebo-controlled study. J Diabetes Complications. 2020 Apr;34(4):107548. doi: 10.1016/j.jdiacomp.2020.107548. Epub 2020 Feb 1.
PubMed 32046931
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intervention With the Glucagon-like Peptide 1 (GLP-1) Analog Liraglutide Plus Metformin Versus Metformin Monotherapy in Overweight/Obese Women With Metabolic Defects and Recent History of Gestational Diabetes Mellitus (GDM)
- ClinicalTrials.gov ID
- NCT01234649
- Acronym / sponsor ID
- RP10-012
- Conditions
- Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus, Metabolic Syndrome, Impaired Glucose Tolerance, Disorder of Glucose Regulation
- Keywords
- gestational diabetes mellitus, type 2 diabetes mellitus, metabolic dysfunction, impaired fasting glucose, impaired glucose tolerance, incretin mimetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 11 Aug 2011 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with prior GDM.
Detailed description
Gestational diabetes is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. . Despite the high and increasing rate of type 2 diabetes in Louisiana, the medical community does not have reliable estimates of the number of woman living in southern Louisiana who develop diabetes subsequent to GDM. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater than control groups who did not have glucose intolerance during pregnancy. The higher rates were in studies of particular ethnic groups in the U.S. Recently, follow-up programs elsewhere also have identified increasing rates of type 2 diabetes by 5-10 years after GDM: 9-43% type 2 diabetes in Europe and 11-21% in Asia. The frequency of type 2 diabetes is influenced by BMI, weight gain after pregnancy, family history of diabetes, fasting and postchallenge glucose levels during and after pregnancy, postpartum insulin resistance and inadequate β-cell secretion, and the need for pharmacological treatment during pregnancy. However, the risk factors are unable to predict all cases of subsequent type 2 diabetes: the biggest risk factor is a GDM pregnancy. Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, lifestyle modification and pharmacological therapies. Lifestyle intervention was found to reduce the incidence of type 2 diabetes by 58% and metformin by 31% as compared with placebo. The use of rosiglitazone in subjects with prediabetes resulted in a 60% reduction of the diabetes incidence rate. Studies are needed for optimal postpartum and long-term health of women who have had GDM. Considerable recent evidence suggests that incretin-based therapies may be useful for the treatment of DM2 because continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial improvements in glucose control and ß-cell function in subjects with type 2 diabetes. Infusion of GLP-1 improves first and second-phase insulin secretion suggesting that early GLP-1 therapy may preserve ß-cell function in subjects with IGT or mild DM2. Whereas native GLP-1 has a very short half-life, the GLP-1 analogue liraglutide has a prolonged action (t1/2=13 h) suitable for once-daily injection. Liraglutide may potentially delay disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving metabolic parameters in at-risk overweight/obese women with prior GDM
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin XR plus liraglutide | Experimental | Drug: Metformin XR plus liraglutideMetformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated |
| Metformin XR plus placebo | Active comparator | Drug: Metformin XR plus placeboMetformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult female 18 years to 45 years of age who experienced GDM within 52 weeks of index pregnancy
- Actual BMI >25 kg/ m2
- Written consent for participation in the study
- Patient completed lactation
- Dysglycemia (impaired fasting glucose [IFG}, impaired glucose tolerance [IGT} or IFG/IGT) and/or ß-cell dysfunction postpartum requiring pharmacological intervention (except type 1 or 2 diabetes)
Key exclusion criteria (18 listed)
- Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
- History of pancreatitis
- Significant cardiovascular, cerebrovascular, renal, or hepatobiliary diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)
- Serum liver enzymes (AST and/or ALT levels) exceeding more than twice normal laboratory values
- Uncontrolled hypertension (systolic blood pressure>150 mm Hg and/or diastolic blood pressure >90 mm Hg)
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 |
|---|---|---|
| Metformin XR plus placeboAlso: Metformin XR is genericMetformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated | Drug | Metformin XR plus placebo |
| Metformin XR plus liraglutideAlso: VictozaMetformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD) | Drug | Metformin XR plus liraglutide |
Primary outcome
Insulin Secretion-Sensitivity Index (IS-SI)
Time frame: 84 weeks of treatment
IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET)
21 secondary outcomes
Fasting Blood Glucose (FBG)
Time frame: 84 weeks of treatment
Mean Glucose During OGTT (MBG)
Time frame: 84 weeks of treatment
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 84 weeks of treatment
Matsuda Insulin Sensitivity Index Derived From OGTT
Time frame: 84 weeks of treatment
Insulinogenic Index (IGI) /HOMA-IR
Time frame: 84 weeks of treatment
Absolute Body Weight
Time frame: 84 weeks of treatment
Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)
Time frame: Change from baseline (time 0) to study end (84 weeks)
Body Mass Index (BMI)
Time frame: 84 weeks of treatment
Waist Circumference (WC)
Time frame: 84 weeks of treatment
Waist-to-Hip Ratio (WHR)
Time frame: 84 weeks of treatment
Waist to Height Ratio (WHtR)
Time frame: 84 weeks of treatment
Total Cholesterol (CHOL) Levels
Time frame: 84 weeks of treatment
High Density Lipoprotein Cholesterol (HDL-C) Levels
Time frame: 84 weeks of treatment
Low Density Lipoprotein Cholesterol (LDL-C) Levels
Time frame: 84 weeks of treatment
Triglyceride (TRG) Levels
Time frame: 84 weeks of treatment
Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)
Time frame: 84 weeks of treatment
Systolic Blood Pressure
Time frame: 84 weeks of treatment
Diastolic Blood Pressure
Time frame: 84 weeks of treatment
Alanine Aminotransferase (ALT) Levels
Time frame: 84 weeks of treatment
Aspartate Aminotransferase (AST)
Time frame: 84 weeks of treatment
Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio
Time frame: 84 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32046931Elkind-Hirsch KE, Shaler D, Harris R. Postpartum treatment with liraglutide in combination with metformin versus metformin monotherapy to improve metabolic status and reduce body weight in overweight/obese women with recent gestational diabetes: A double-blind, randomized, placebo-controlled study. J Diabetes Complications. 2020 Apr;34(4):107548. doi: 10.1016/j.jdiacomp.2020.107548. Epub 2020 Feb 1.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
Woman's Hospital, Louisiana
Renee Harris, M.D. study director
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 Metformin XR plus liraglutide in people with Gestational Diabetes Mellitus and Type 2 Diabetes Mellitus, 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 18 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 26 Jul 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 26 Jul 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?
Insulin Secretion-Sensitivity Index (IS-SI) (time frame: 84 weeks of treatment). 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 NCT01234649, 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 26 Jul 2019.