Non Insulin Dependent DiabetesPhase 2MIPODNCT00835861
Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
A Phase 2 study testing Metformin and Insulin in people with Non Insulin Dependent Diabetes and Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non Insulin Dependent Diabetes, Pregnancy
- What is being tested?
- Metformin and Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2010
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
- Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
- Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
- Less than 24 weeks at study enrollment
- Singleton or twin pregnancy
- English or Spanish speaking
- Able to give informed consent
Who cannot join
- End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
- Prior need for insulin for glycemic control
- History of diabetic ketoacidosis (DKA) or hyperosmolar state
- Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
- Kidney or liver disease
- Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals Obstetric Clinics
Chapel Hill, North Carolina, 27599
About this study
Official title: Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.
Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
- Conditions
- Non Insulin Dependent Diabetes, Pregnancy
- Keywords
- Non Insulin Dependent Diabetes, Pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education. They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control. If glycemic control can not be achieved with Metformin as a single agent insulin will be added.
InsulinDrug
Also called Regular Insulin, Novolin R, Humulin R, NPH Insulin
Women randomized to the Insulin group will receive standard diet and glycemic monitoring education. They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group. Receives: Drug: Metformin |
| Insulin | Active comparator | Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Measurements
Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
Measured: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
Secondary outcomes (8)
Number of Patients With Obstetric Complications
Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.
Measured: Throughout pregnancy until hospital discharge following delivery.
Maternal Weight Gain
Measured: Baseline throughout pregnancy until last prenatal visit.
Number of Babies With Neonatal Hypoglycemia
Initial neonatal glucose < 40 mg/dL
Measured: Time of delivery through hospital discharge
Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
Measured: 1st, 2nd, and 3rd trimester
Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95
Measured: Baseline throughout pregnancy until time of delivery
Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130
Measured: Baseline throughout pregnancy until time of delivery
Number of Episodes Maternal Hypoglycemia
Maternal glucose < 60 mg/dL
Measured: Baseline throughout pregnancy until time of delivery
Number of Babies With Adverse Neonatal Outcomes
Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.
Measured: Delivery until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionApr 2010
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 Non Insulin Dependent DiabetesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- WakeMed Health and Hospitals
- Responsible party
- Sponsor
- Investigators
- Ashley Hickman, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835861
- Sponsor's protocol ID
- UNC08-0898
- Acronym
- MIPOD
- Status last verified
- Apr 2014
- First submitted
- 2 Feb 2009
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hickman MA, McBride R, Boggess KA, Strauss R. Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. Am J Perinatol. 2013 Jun;30(6):483-90. doi: 10.1055/s-0032-1326994. Epub 2012 Oct 24.
PubMed 23096052
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)
- ClinicalTrials.gov ID
- NCT00835861
- Acronym / sponsor ID
- MIPOD / UNC08-0898
- Conditions
- Non Insulin Dependent Diabetes, Pregnancy
- Keywords
- Non Insulin Dependent Diabetes, Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- WakeMed Health and Hospitals
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.
Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminWomen who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group. |
| Insulin | Active comparator | Drug: InsulinWomen who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
- Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
- Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
- Less than 24 weeks at study enrollment
- Singleton or twin pregnancy
Key exclusion criteria (6 listed)
- End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
- Prior need for insulin for glycemic control
- History of diabetic ketoacidosis (DKA) or hyperosmolar state
- Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
- Kidney or liver disease
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 |
|---|---|---|
| MetforminAlso: GlucophageWomen randomized to the Experimental arm will receive standard diet and glucose self-monitoring education. They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control. If glycemic control can not be achieved with Metformin as a single agent insulin will be added. | Drug | Metformin |
| InsulinAlso: Regular Insulin, Novolin R, Humulin R, NPH InsulinWomen randomized to the Insulin group will receive standard diet and glycemic monitoring education. They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130. | Drug | Insulin |
Primary outcome
Blood Glucose Measurements
Time frame: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery
Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
8 secondary outcomes
Number of Patients With Obstetric Complications
Time frame: Throughout pregnancy until hospital discharge following delivery.
Maternal Weight Gain
Time frame: Baseline throughout pregnancy until last prenatal visit.
Number of Babies With Neonatal Hypoglycemia
Time frame: Time of delivery through hospital discharge
Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester
Time frame: 1st, 2nd, and 3rd trimester
Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)
Time frame: Baseline throughout pregnancy until time of delivery
Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)
Time frame: Baseline throughout pregnancy until time of delivery
Number of Episodes Maternal Hypoglycemia
Time frame: Baseline throughout pregnancy until time of delivery
Number of Babies With Adverse Neonatal Outcomes
Time frame: Delivery until hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23096052Hickman MA, McBride R, Boggess KA, Strauss R. Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. Am J Perinatol. 2013 Jun;30(6):483-90. doi: 10.1055/s-0032-1326994. Epub 2012 Oct 24.
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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.
Ashley Hickman, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Insulin in people with Non Insulin Dependent Diabetes and Pregnancy, run by University of North Carolina, Chapel Hill 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 7 inclusion and 6 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 25 Apr 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 May 2014). 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?
Blood Glucose Measurements (time frame: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery). 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 NCT00835861, 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 25 Apr 2017.