Trial · NCT01837680

Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy

NCT01837680, Not applicable, Completed, St. Luke's-Roosevelt Hospital Center; results first posted 2017-05-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy. Trials, record NCT01837680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01837680

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy
NCT number: NCT01837680
Status: Completed
Phases: Not applicable
Enrollment: 105 participants, actual
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Conditions: Diabetes, Gestational, Diabetes, Type 2
Interventions: Insulin
First posted: 2013-04-23
Last updated: 2017-05-30
Results first posted: 2017-05-30

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Glycemic Control	up to 41 weeks	Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.
Secondary	Number of Patients Obtaining Glycemic Control	up to 41 weeks	Number of each group that obtains glycemic control, defined as mean glucose \<100mg/dl.
Secondary	Time to Achieve Glycemic Control	up to 41 weeks	Time (weeks) to achieve glycemic control, as defined as mean glucose \<100mg/dl
Secondary	Average Fasting Glucose	up to 41 weeks	Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits
Secondary	Post-prandial Blood Glucose	up to 41 weeks	Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits.
Secondary	Weight Gain	Number of pounds gained at each visit up to 41 weeks	Total weight gain in pregnancy
Secondary	Neonatal Weight	At delivery, up to 41 weeks	Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight \>90th percentile for gestational age
Secondary	Gestational Age at Delivery	at delivery, up to 41 weeks	Gestational age at delivery
Secondary	Maternal Hypoglycemia	at delivery, up to 41 weeks	Number of participants with incidence of maternal hypoglycemia (\<60mg/dl)
Secondary	Neonatal Bilirubin	at birth, up to 41 weeks	Percentage of neonatal hyperbilirubinemia - data not collected

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Glycemic Control	up to 41 weeks	mg/dL	MEAN
SECONDARY	Number of Patients Obtaining Glycemic Control	up to 41 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Achieve Glycemic Control	up to 41 weeks	weeks	MEDIAN
SECONDARY	Average Fasting Glucose	up to 41 weeks	mg/dL	MEAN
SECONDARY	Post-prandial Blood Glucose	up to 41 weeks	mg/dL	MEAN
SECONDARY	Weight Gain	Number of pounds gained at each visit up to 41 weeks	lbs	MEAN
SECONDARY	Neonatal Weight	At delivery, up to 41 weeks	g	MEDIAN
SECONDARY	Gestational Age at Delivery	at delivery, up to 41 weeks	weeks	MEDIAN
SECONDARY	Maternal Hypoglycemia	at delivery, up to 41 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Neonatal Bilirubin	at birth, up to 41 weeks

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Glycemic Control	Insulin NPH	109.5	Standard Deviation 10.0	mg/dL
Glycemic Control	Levemir	107.4	Standard Deviation 7.1	mg/dL
Number of Patients Obtaining Glycemic Control	Insulin NPH	28		Participants
Number of Patients Obtaining Glycemic Control	Levemir	35		Participants
Time to Achieve Glycemic Control	Insulin NPH	5	Full Range 3 to 9	weeks
Time to Achieve Glycemic Control	Levemir	5	Full Range 4 to 7	weeks
Average Fasting Glucose	Insulin NPH	100.7	Standard Deviation 10.1	mg/dL
Average Fasting Glucose	Levemir	97.3	Standard Deviation 7.4	mg/dL
Post-prandial Blood Glucose	Insulin NPH	115.2	Standard Deviation 10.2	mg/dL
Post-prandial Blood Glucose	Levemir	112.9	Standard Deviation 8.9	mg/dL

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Insulin NPH	52
Overall Study	STARTED	Levemir	53
Overall Study	COMPLETED	Insulin NPH	42
Overall Study	COMPLETED	Levemir	45
Overall Study	NOT COMPLETED	Insulin NPH	10
Overall Study	NOT COMPLETED	Levemir	8

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rash	Skin and subcutaneous tissue disorders	Insulin NPH	6	52	6
other	Rash	Skin and subcutaneous tissue disorders	Levemir	0	53	0
other	Symptomatic hypoglycemia	Metabolism and nutrition disorders	Insulin NPH	11	52	28
other	Symptomatic hypoglycemia	Metabolism and nutrition disorders	Levemir	16	53	102
other	biochemical event of hypoglycemia	Metabolism and nutrition disorders	Insulin NPH	14	52	26
other	biochemical event of hypoglycemia	Metabolism and nutrition disorders	Levemir	27	53	136
other	Symptomatic nocturnal event	Metabolism and nutrition disorders	Insulin NPH	2	52
other	Symptomatic nocturnal event	Metabolism and nutrition disorders	Levemir	8	53

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Insulin NPH	0	52
Total, all-cause mortality	Levemir	0	53
Total, other adverse events	Insulin NPH	27	52
Total, other adverse events	Levemir	45	53
Total, serious adverse events	Insulin NPH	0	52
Total, serious adverse events	Levemir	0	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26070699	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Insulin NPH vs Levemir: Number of Patients Obtaining Glycemic Control	Trial comparisons
Insulin NPH vs Levemir: Birth Rate	Trial comparisons
Insulin NPH vs Levemir: Neonatal Hypoglycemia	Trial comparisons
Insulin NPH vs Levemir: Maternal Hypoglycemia	Trial comparisons
Insulin NPH vs Levemir: deaths from any cause	Trial comparisons
Insulin NPH vs Levemir: Intensive Care Admissions	Trial comparisons
Insulin NPH vs Levemir: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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