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Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

This study has been completed.
Sponsor:
Collaborators:
International Diabetes Center at Park Nicollet
Sanofi
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT01089569
First received: March 17, 2010
Last updated: April 19, 2017
Last verified: October 2013

March 17, 2010
April 19, 2017
April 2010
May 2013   (Final data collection date for primary outcome measure)
HbA1c Change [ Time Frame: baseline to final visit (32 weeks) ]

Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination.

Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.

Continuous Glucose Monitoring [ Time Frame: 40 weeks ]

Employ CGM with AGP analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) ii. Glucose variability (inter-quartile range) iii. Glucose stability (hourly change in the median curve iv. Incidence of hypoglycemia (degree, duration, frequency)

Complete list of historical versions of study NCT01089569 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Incidence of Hypoglycemia (Frequency) [ Time Frame: baseline to final visit (32 weeks) ]

    Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

    Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency)

    Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)

  • Change From Baseline in Incidence of Hypoglycemia (Degree) [ Time Frame: baseline to final visit (32 weeks) ]

    Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

    Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)

  • Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve) [ Time Frame: baseline to final visit (32 weeks) ]

    Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

    Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve)

    Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (|p subscript 50 zero - p subscript 50 23|+Sum superscript 23 subscript i = 1| p subscript 50i - p subscript 50 i-1| over T.

    i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles

  • Change From Baseline in CGM Glucose Variability [ Time Frame: baseline to final visit (32 weeks) ]

    Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

    Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range)

    IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks).

  • Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC) [ Time Frame: baseline - final visit (32 weeks) ]

    Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.

    Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks).

    AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day

  • Change From Baseline in Weight Changes [ Time Frame: baseline - final visit (32 weeks) ]

    Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.

    Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.

    Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks).

Continuous Glucose Monitoring and Lab Tests [ Time Frame: 40 weeks ]

Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.

Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.

Not Provided
Not Provided
 
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.

An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Masking Description:
Subjects were randomized and then told the medications they were randomized to. Since the medications were already on the market, there was no need for masking for any involved individuals.
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Exenatide
    5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
    Other Name: Bydureon
  • Drug: Insulin Glargine
    .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
    Other Name: Lantus
  • Active Comparator: Exenatide
    5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
    Intervention: Drug: Exenatide
  • Active Comparator: Insulin Glargine
    .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
    Intervention: Drug: Insulin Glargine
  • Active Comparator: Exenatide + Insulin Glargine

    Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

    + Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

    Interventions:
    • Drug: Exenatide
    • Drug: Insulin Glargine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects ≥18 and ≤75 years of age
  • Clinical diagnosis of type 2 diabetes
  • Diabetes duration ≥ 1 year
  • HbA1c ≥7.0%
  • Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion Criteria:

  • Previously treated with insulin or incretin-based therapy
  • Treated with a thiazolidinedione within past 6 weeks
  • Taken oral or injected prednisone or cortisone medications in the previous 30 days
  • Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)
  • Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)
  • eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)
  • ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)
  • Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study
  • Currently pregnant or planning pregnancy during the study period
  • Unable to follow the study protocol
  • Unable to speak, read and write in English
  • Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy
  • At the investigator's discretion for other medical or psychological reasons
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01089569
03951-10-C
No
Not Provided
No
Not Provided
HealthPartners Institute
HealthPartners Institute
  • International Diabetes Center at Park Nicollet
  • Sanofi
Principal Investigator: Richard M Bergenstal, MD International Diabetes Center at Park Nicollet
Principal Investigator: Roger S Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Elinor S Strock, APRN International Diabetes Center at Park Nicollet
HealthPartners Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP