Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes: Continuous glucose monitoring profiles and variability using morning or evening injections

Richard M. Bergenstal, Timothy S. Bailey, David Rodbard, Monika Ziemen, Hailing Guo, Isabel Muehlen-Bartmer, Andrew Ahmann

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

OBJECTIVE The objective of this study was to compare glucose control in participants with type 1 diabetes receiving insulin glargine 300 units/mL (Gla-300) or glargine 100 units/mL (Gla-100) in the morning or evening, in combination with mealtime insulin. RESEARCH DESIGN AND METHODS In this 16-week, exploratory, open-label, parallel-group, two-period crossover study (clinicaltrials.gov identifier NCT01658579), 59 adults with type 1 diabetes were randomized (1:1:1:1) to once-daily Gla-300 or Gla-100 given in the morning or evening (with crossover in the injection schedule). The primary efficacy end point was the mean percentage of time in the target glucose range (80-140 mg/dL), as measured using continuous glucose monitoring (CGM), during the last 2 weeks of each 8-week period. Additional end points included other CGM glycemic control parameters, hypoglycemia (per self-monitored plasma glucose [SMPG]), and adverse events. RESULTS The percentage of time within the target glucose range was comparable between the Gla-300 and Gla-100 groups. There was significantly less increase in CGMbased glucose during the last 4 h of the 24-h injection interval for Gla-300 compared with Gla-100 (least squares mean difference 214.7 mg/dL [95% CI 226.9 to 22.5]; P = 0.0192). Mean 24-h glucose curves for the Gla-300 group were smoother (lower glycemic excursions), irrespective of morning or evening injection. Four metrics of intrasubject interstitial glucose variability showed no difference between Gla-300 and Gla-100. Nocturnal confirmed (<54 mg/dL by SMPG) or severe hypoglycemia rate was lower for Gla-300 participants than for Gla-100 participants (4.0 vs. 9.0 events per participant-year; rate ratio 0.45 [95% CI 0.24-0.82]). CONCLUSIONS Less increase in CGM-based glucose levels in the last 4 h of the 24-h injection interval, smoother average 24-h glucose profiles irrespective of injection time, and reduced nocturnal hypoglycemia were observed with Gla-300 versus Gla-100.

Original languageEnglish (US)
Pages (from-to)554-560
Number of pages7
JournalDiabetes Care
Volume40
Issue number4
DOIs
StatePublished - Apr 1 2017

Fingerprint

Type 1 Diabetes Mellitus
Glucose
Injections
Hypoglycemia
Insulin Glargine
Least-Squares Analysis
Cross-Over Studies
Meals
Appointments and Schedules

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes : Continuous glucose monitoring profiles and variability using morning or evening injections. / Bergenstal, Richard M.; Bailey, Timothy S.; Rodbard, David; Ziemen, Monika; Guo, Hailing; Muehlen-Bartmer, Isabel; Ahmann, Andrew.

In: Diabetes Care, Vol. 40, No. 4, 01.04.2017, p. 554-560.

Research output: Contribution to journalArticle

Bergenstal, Richard M. ; Bailey, Timothy S. ; Rodbard, David ; Ziemen, Monika ; Guo, Hailing ; Muehlen-Bartmer, Isabel ; Ahmann, Andrew. / Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes : Continuous glucose monitoring profiles and variability using morning or evening injections. In: Diabetes Care. 2017 ; Vol. 40, No. 4. pp. 554-560.
@article{344533e5512445e3934d9e59855b9e04,
title = "Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes: Continuous glucose monitoring profiles and variability using morning or evening injections",
abstract = "OBJECTIVE The objective of this study was to compare glucose control in participants with type 1 diabetes receiving insulin glargine 300 units/mL (Gla-300) or glargine 100 units/mL (Gla-100) in the morning or evening, in combination with mealtime insulin. RESEARCH DESIGN AND METHODS In this 16-week, exploratory, open-label, parallel-group, two-period crossover study (clinicaltrials.gov identifier NCT01658579), 59 adults with type 1 diabetes were randomized (1:1:1:1) to once-daily Gla-300 or Gla-100 given in the morning or evening (with crossover in the injection schedule). The primary efficacy end point was the mean percentage of time in the target glucose range (80-140 mg/dL), as measured using continuous glucose monitoring (CGM), during the last 2 weeks of each 8-week period. Additional end points included other CGM glycemic control parameters, hypoglycemia (per self-monitored plasma glucose [SMPG]), and adverse events. RESULTS The percentage of time within the target glucose range was comparable between the Gla-300 and Gla-100 groups. There was significantly less increase in CGMbased glucose during the last 4 h of the 24-h injection interval for Gla-300 compared with Gla-100 (least squares mean difference 214.7 mg/dL [95{\%} CI 226.9 to 22.5]; P = 0.0192). Mean 24-h glucose curves for the Gla-300 group were smoother (lower glycemic excursions), irrespective of morning or evening injection. Four metrics of intrasubject interstitial glucose variability showed no difference between Gla-300 and Gla-100. Nocturnal confirmed (<54 mg/dL by SMPG) or severe hypoglycemia rate was lower for Gla-300 participants than for Gla-100 participants (4.0 vs. 9.0 events per participant-year; rate ratio 0.45 [95{\%} CI 0.24-0.82]). CONCLUSIONS Less increase in CGM-based glucose levels in the last 4 h of the 24-h injection interval, smoother average 24-h glucose profiles irrespective of injection time, and reduced nocturnal hypoglycemia were observed with Gla-300 versus Gla-100.",
author = "Bergenstal, {Richard M.} and Bailey, {Timothy S.} and David Rodbard and Monika Ziemen and Hailing Guo and Isabel Muehlen-Bartmer and Andrew Ahmann",
year = "2017",
month = "4",
day = "1",
doi = "10.2337/dc16-0684",
language = "English (US)",
volume = "40",
pages = "554--560",
journal = "Diabetes Care",
issn = "1935-5548",
publisher = "American Diabetes Association Inc.",
number = "4",

}

TY - JOUR

T1 - Comparison of insulin glargine 300 units/mL and 100 units/mL in adults with type 1 diabetes

T2 - Continuous glucose monitoring profiles and variability using morning or evening injections

AU - Bergenstal, Richard M.

AU - Bailey, Timothy S.

AU - Rodbard, David

AU - Ziemen, Monika

AU - Guo, Hailing

AU - Muehlen-Bartmer, Isabel

AU - Ahmann, Andrew

PY - 2017/4/1

Y1 - 2017/4/1

N2 - OBJECTIVE The objective of this study was to compare glucose control in participants with type 1 diabetes receiving insulin glargine 300 units/mL (Gla-300) or glargine 100 units/mL (Gla-100) in the morning or evening, in combination with mealtime insulin. RESEARCH DESIGN AND METHODS In this 16-week, exploratory, open-label, parallel-group, two-period crossover study (clinicaltrials.gov identifier NCT01658579), 59 adults with type 1 diabetes were randomized (1:1:1:1) to once-daily Gla-300 or Gla-100 given in the morning or evening (with crossover in the injection schedule). The primary efficacy end point was the mean percentage of time in the target glucose range (80-140 mg/dL), as measured using continuous glucose monitoring (CGM), during the last 2 weeks of each 8-week period. Additional end points included other CGM glycemic control parameters, hypoglycemia (per self-monitored plasma glucose [SMPG]), and adverse events. RESULTS The percentage of time within the target glucose range was comparable between the Gla-300 and Gla-100 groups. There was significantly less increase in CGMbased glucose during the last 4 h of the 24-h injection interval for Gla-300 compared with Gla-100 (least squares mean difference 214.7 mg/dL [95% CI 226.9 to 22.5]; P = 0.0192). Mean 24-h glucose curves for the Gla-300 group were smoother (lower glycemic excursions), irrespective of morning or evening injection. Four metrics of intrasubject interstitial glucose variability showed no difference between Gla-300 and Gla-100. Nocturnal confirmed (<54 mg/dL by SMPG) or severe hypoglycemia rate was lower for Gla-300 participants than for Gla-100 participants (4.0 vs. 9.0 events per participant-year; rate ratio 0.45 [95% CI 0.24-0.82]). CONCLUSIONS Less increase in CGM-based glucose levels in the last 4 h of the 24-h injection interval, smoother average 24-h glucose profiles irrespective of injection time, and reduced nocturnal hypoglycemia were observed with Gla-300 versus Gla-100.

AB - OBJECTIVE The objective of this study was to compare glucose control in participants with type 1 diabetes receiving insulin glargine 300 units/mL (Gla-300) or glargine 100 units/mL (Gla-100) in the morning or evening, in combination with mealtime insulin. RESEARCH DESIGN AND METHODS In this 16-week, exploratory, open-label, parallel-group, two-period crossover study (clinicaltrials.gov identifier NCT01658579), 59 adults with type 1 diabetes were randomized (1:1:1:1) to once-daily Gla-300 or Gla-100 given in the morning or evening (with crossover in the injection schedule). The primary efficacy end point was the mean percentage of time in the target glucose range (80-140 mg/dL), as measured using continuous glucose monitoring (CGM), during the last 2 weeks of each 8-week period. Additional end points included other CGM glycemic control parameters, hypoglycemia (per self-monitored plasma glucose [SMPG]), and adverse events. RESULTS The percentage of time within the target glucose range was comparable between the Gla-300 and Gla-100 groups. There was significantly less increase in CGMbased glucose during the last 4 h of the 24-h injection interval for Gla-300 compared with Gla-100 (least squares mean difference 214.7 mg/dL [95% CI 226.9 to 22.5]; P = 0.0192). Mean 24-h glucose curves for the Gla-300 group were smoother (lower glycemic excursions), irrespective of morning or evening injection. Four metrics of intrasubject interstitial glucose variability showed no difference between Gla-300 and Gla-100. Nocturnal confirmed (<54 mg/dL by SMPG) or severe hypoglycemia rate was lower for Gla-300 participants than for Gla-100 participants (4.0 vs. 9.0 events per participant-year; rate ratio 0.45 [95% CI 0.24-0.82]). CONCLUSIONS Less increase in CGM-based glucose levels in the last 4 h of the 24-h injection interval, smoother average 24-h glucose profiles irrespective of injection time, and reduced nocturnal hypoglycemia were observed with Gla-300 versus Gla-100.

UR - http://www.scopus.com/inward/record.url?scp=85019629780&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019629780&partnerID=8YFLogxK

U2 - 10.2337/dc16-0684

DO - 10.2337/dc16-0684

M3 - Article

C2 - 28115474

AN - SCOPUS:85019629780

VL - 40

SP - 554

EP - 560

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

IS - 4

ER -