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Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy.

Ainuddin JA, Karim N, Zaheer S, Ali SS, Hasan AA - J Diabetes Res (2015)

Bottom Line: Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma.Neonatal hypoglycemia was significantly less and so was NICU stay of >24 hours in metformin group (P < 0.01).Significant reduction in cost of treatment was found in metformin group.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Dow University of Health Sciences, Karachi 74400, Pakistan.

ABSTRACT

Aims: To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability.

Methods: In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma.

Results: Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P < 0.001) and pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P < 0.01). Neonatal hypoglycemia was significantly less and so was NICU stay of >24 hours in metformin group (P < 0.01). Significant reduction in cost of treatment was found in metformin group.

Conclusion: Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

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Related in: MedlinePlus

Flow diagram of study enrollment.
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Related In: Results  -  Collection


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fig1: Flow diagram of study enrollment.

Mentions: The overall design and subject flow through the study is illustrated in Figure 1. A total of 297 patients with type 2 diabetes in pregnancy were enrolled for the study. Of these 250 met the inclusion criteria and were randomized to treatment with metformin or insulin. 205 patients were already known cases of type 2 diabetes and were controlled on diet only or were on oral hypoglycemic agents. 45 patients were newly diagnosed cases and were classified as overt diabetes in pregnancy according to IADPSG criteria. 206 participants completed the study and their data was finally analyzed, with 106 patients in metformin group and 100 patients in insulin group (Figure 1). 84.9% patients in metformin group needed supplementary insulin treatment in varying doses to maintain glycemic control. The base line characteristics between the groups were not significantly different in metformin plus insulin and insulin alone groups; however patients in metformin alone group were younger and were of less parity (Table 1).


Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy.

Ainuddin JA, Karim N, Zaheer S, Ali SS, Hasan AA - J Diabetes Res (2015)

Flow diagram of study enrollment.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4385634&req=5

fig1: Flow diagram of study enrollment.
Mentions: The overall design and subject flow through the study is illustrated in Figure 1. A total of 297 patients with type 2 diabetes in pregnancy were enrolled for the study. Of these 250 met the inclusion criteria and were randomized to treatment with metformin or insulin. 205 patients were already known cases of type 2 diabetes and were controlled on diet only or were on oral hypoglycemic agents. 45 patients were newly diagnosed cases and were classified as overt diabetes in pregnancy according to IADPSG criteria. 206 participants completed the study and their data was finally analyzed, with 106 patients in metformin group and 100 patients in insulin group (Figure 1). 84.9% patients in metformin group needed supplementary insulin treatment in varying doses to maintain glycemic control. The base line characteristics between the groups were not significantly different in metformin plus insulin and insulin alone groups; however patients in metformin alone group were younger and were of less parity (Table 1).

Bottom Line: Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma.Neonatal hypoglycemia was significantly less and so was NICU stay of >24 hours in metformin group (P < 0.01).Significant reduction in cost of treatment was found in metformin group.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Dow University of Health Sciences, Karachi 74400, Pakistan.

ABSTRACT

Aims: To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability.

Methods: In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma.

Results: Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P < 0.001) and pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P < 0.01). Neonatal hypoglycemia was significantly less and so was NICU stay of >24 hours in metformin group (P < 0.01). Significant reduction in cost of treatment was found in metformin group.

Conclusion: Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

Show MeSH
Related in: MedlinePlus