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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

NCTNCT00765817 (opens ClinicalTrials.gov in a new tab)Other idH8O-US-GWCO
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
261 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
6 countries

United States, Greece, Israel, Mexico, Puerto Rico, United Kingdom

Start
Oct 2008
Primary completion
Jan 2010
Completion
Jan 2010
First posted
3 Oct 2008 (estimated)
Last update posted
24 Oct 2016 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011
  1. Ph 3

    Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

    NCT00765817

    Oct 2008 to Jan 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Interventions

  • placeboDrug
  • exenatideDrug

Arms2

  • Placebo comparator

    1

  • Experimental

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame · baseline and 30 weeks

    Registry description

    Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.

Secondary outcomes(16)

  1. Percentage of Patients Achieving HbA1c <=7%

    Time frame · baseline and 30 weeks

    Registry description

    Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 30 (percentage = \[number of subjects with HbA1c \<=7% at week 30 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).

  2. Percentage of Patients Achieving HbA1c <=6.5%

    Time frame · baseline and 30 weeks

    Registry description

    Percentage of patients in each arm who had HbA1c \>6.5% at baseline and had HbA1c \<=6.5% at week 30 (percentage = \[number of subjects with HbA1c \<=6.5% at week 30 divided by number of subjects with HbA1c \>6.5% at baseline\] \* 100%).

  3. Change in Fasting Serum Glucose

    Time frame · baseline and 30 weeks

    Registry description

    Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)

  4. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

    Time frame · baseline and 30 weeks

    Registry description

    Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)

  5. Change in Total Cholesterol

    Time frame · baseline and 30 weeks

    Registry description

    Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)

  6. Change in Low Density Lipoprotein (LDL) Cholesterol

    Time frame · baseline and 30 weeks

    Registry description

    Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)

  7. Change in High Density Lipoprotein (HDL) Cholesterol

    Time frame · baseline and 30 weeks

    Registry description

    Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)

  8. Change in Triglycerides

    Time frame · baseline and 30 weeks

    Registry description

    Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)

  9. Change in Body Weight

    Time frame · baseline and 30 weeks

    Registry description

    Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)

  10. Change in Waist Circumference

    Time frame · baseline and 30 weeks

    Registry description

    Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)

  11. Change in Daily Insulin Dose

    Time frame · baseline and 30 weeks

    Registry description

    Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)

  12. Change in Daily Insulin Dose (on a Per Body Weight Basis)

    Time frame · baseline and 30 weeks

    Registry description

    Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)

  13. Change in Systolic Blood Pressure (SBP)

    Time frame · baseline and 30 weeks

    Registry description

    Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)

  14. Change in Diastolic Blood Pressure (DBP)

    Time frame · baseline and 30 weeks

    Registry description

    Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)

  15. Minor Hypoglycemia Rate Per Year

    Time frame · baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

    Registry description

    Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL).

  16. Percentage of Subjects Experiencing Minor Hypoglycemia

    Time frame · baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

    Registry description

    Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· baseline and 30 weeks

Change in Glycosylated Hemoglobin (HbA1c)

GroupValue (percentage of hemoglobin)Spread
Exenatide Arm-1.710.09
Placebo Arm-1.000.09
Secondary and other outcome results(7)
Secondary outcomeNumber· baseline and 30 weeks

Percentage of Patients Achieving HbA1c <=7%

GroupValue (percentage)
Exenatide Arm58.3
Placebo Arm31.1
Secondary outcomeNumber· baseline and 30 weeks

Percentage of Patients Achieving HbA1c <=6.5%

GroupValue (percentage)
Exenatide Arm42.0
Placebo Arm13.3
Secondary outcomeLeast squares mean· baseline and 30 weeks

Change in Fasting Serum Glucose

GroupValue (mmol/L)Spread
Exenatide Arm-1.280.2
Placebo Arm-0.870.2
Secondary outcomeLeast squares mean· baseline and 30 weeks

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

GroupValue (mmol/L)Spread
Exenatide Arm7.890.2
Placebo Arm8.270.2
Secondary outcomeLeast squares mean· baseline and 30 weeks

Change in Total Cholesterol

GroupValue (mmol/L)Spread
Exenatide Arm-0.160.08
Placebo Arm-0.020.09
Secondary outcomeLeast squares mean· baseline and 30 weeks

Change in Low Density Lipoprotein (LDL) Cholesterol

GroupValue (mmol/L)Spread
Exenatide Arm-0.190.07
Placebo Arm-0.000.07
Secondary outcomeLeast squares mean· baseline and 30 weeks

Change in High Density Lipoprotein (HDL) Cholesterol

GroupValue (mmol/L)Spread
Exenatide Arm0.010.02
Placebo Arm0.000.02

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide ArmExenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)–8 / 137109 / 138
Placebo ArmPlacebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)–11 / 12266 / 123

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2014

13 results

Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration.

Buse et al. 2014Current medical research and opinioncited by 5

PMID 24621255DOI 10.1185/03007995.2014.896329PUB-24621255

Full text at the publisher13 results
Publisher pageSee results (13)

Indexing hint: Randomized controlled trial · 2012

5 results

Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes.

Rosenstock et al. 2012Diabetes carecited by 54

PMID 22432107PMC3329851DOI 10.2337/dc11-1434PUB-22432107

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

PubMed tag: none · 2012

11 results

Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.

Pencek et al. 2012Postgraduate medicinecited by 45

PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891

Full text at the publisher11 results
Publisher pageSee results (11)

Indexing hint: Randomized controlled trial · 2011

10 results

Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial.

Buse et al. 2011Annals of internal medicinecited by 389

PMID 21138825DOI 10.7326/0003-4819-154-2-201101180-00300PUB-21138825

Full text at the publisher10 results
Publisher pageSee results (10)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedZinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5. PMID 23043166

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have type 2 diabetes. * Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study. Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study: 1. metformin (stable dose for 6 weeks) 2. pioglitazone (stable dose for 6 weeks) 3. a combination of metformin and pioglitazone (stable dose for 6 weeks) * Have HbA1C between 7.1% and 10.5%, inclusive. * Have a body mass index (BMI) ≤45 kg/m2. * Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening). Exclusion Criteria: * Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study. * Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study. * Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control. * Women who are breastfeeding. * Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer. * Have had a kidney transplant or are currently on kidney dialysis. * Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years. * Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients. * Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study. * Are currently on a weight-loss program or have been on one within 3 months of entering the study. * Have had a blood transfusion or severe blood loss within 3 months of entering the study. * Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study. * Have an irregular sleep cycle (for example, sleeping during the day and working during the night). * Have a history of pancreatitis. * Have received treatment with an experimental drug within 30 days of entering the study. * If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis. * If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study. * If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

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