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A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00960661
First received: August 17, 2009
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: September 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide
Drug: insulin lispro
Drug: Metformin
Drug: Insulin/ Glargine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1036 patients entered the study, 637 were assigned to the two interventional study groups. 10 patients assigned to treatment groups did not receive study drug.

Reporting Groups
  Description
Enrolled Patients who enrolled in the basal insulin optimization (BIO) phase
Exenatide (BET) Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
Insulin Lispro (BBT) Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)

Participant Flow for 2 periods

Period 1:   Basal Insulin Optimization Phase (BIO)
    Enrolled     Exenatide (BET)     Insulin Lispro (BBT)  
STARTED     1036     0     0  
COMPLETED     637     0     0  
NOT COMPLETED     399     0     0  
Adverse Event                 6                 0                 0  
Lost to Follow-up                 4                 0                 0  
Entry criteria not met                 331                 0                 0  
Withdrawal by Subject                 47                 0                 0  
Physician Decision                 8                 0                 0  
Sponsor decision                 3                 0                 0  

Period 2:   Interventional Phase
    Enrolled     Exenatide (BET)     Insulin Lispro (BBT)  
STARTED     0     316     321  
Intent to Treat Population     0     315 [1]   312 [1]
Per Protocol Population     0     247 [2]   263 [2]
COMPLETED     0     264     275  
NOT COMPLETED     0     52     46  
Adverse Event                 0                 17                 8  
Death                 0                 1                 0  
Lost to Follow-up                 0                 0                 2  
entry criteria not met                 0                 3                 0  
Protocol Violation                 0                 7                 2  
Withdrawal by Subject                 0                 18                 29  
Physician Decision                 0                 3                 5  
sponsor decision                 0                 1                 0  
Lack of Efficacy                 0                 2                 0  
[1] all randomized participants who took at least one dose of study drug
[2] all randomized participants who completed study and had no violations



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
per protocol population

Reporting Groups
  Description
Exenatide (BET) Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
Insulin Lispro (BBT) Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
Total Total of all reporting groups

Baseline Measures
    Exenatide (BET)     Insulin Lispro (BBT)     Total  
Number of Participants  
[units: participants]
  247     263     510  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     180     182     362  
>=65 years     67     81     148  
Age  
[units: years]
Mean ± Standard Deviation
  59.5  ± 9.6     59.4  ± 9.27     59.5  ± 9.43  
Gender  
[units: participants]
     
Female     119     130     249  
Male     128     133     261  
prior use of Sulfonylurea (SU)  
[units: participants]
     
YES     85     99     184  
NO     162     164     326  
Glycosylated hemoglobin (HbA1c)  
[units: Percent]
Mean ± Standard Deviation
  8.27  ± 0.983     8.21  ± 0.871     8.24  ± 0.927  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30   [ Time Frame: Baseline, 30 weeks ]

2.  Secondary:   Percentage of Participants Achieving HbA1C < 7.0%   [ Time Frame: Week 30 ]

3.  Secondary:   Percent of Participants Achieving HbA1c ≤ 6.5%.   [ Time Frame: Week 30 ]

4.  Secondary:   Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.   [ Time Frame: Baseline, Week 30 ]

5.  Secondary:   Change in Total Cholesterol From Baseline to Week 30   [ Time Frame: Baseline, week 30 ]

6.  Secondary:   Change in High Density Lipoprotein (HDL) From Baseline to Week 30   [ Time Frame: Baseline, week 30 ]

7.  Secondary:   Change in Low Density Lipoprotein (LDL) From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

8.  Secondary:   Change in Body Weight From Baseline to Week 30.   [ Time Frame: baseline, week 30 ]

9.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

10.  Secondary:   Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30   [ Time Frame: baseline, Week 30 ]

11.  Secondary:   Daily Insulin Glargine Dose at Baseline and at Week 30   [ Time Frame: Baseline, week 30 ]

12.  Secondary:   Major Hypoglycemia Rate Per Year   [ Time Frame: 30 weeks ]

13.  Secondary:   Minor Hypoglycemia Rate Per Year   [ Time Frame: 30 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Research and Development
Organization: Amylin Pharmaceuticals, LLC
e-mail: clinical.trials@BMS.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00960661     History of Changes
Other Study ID Numbers: H8O-EW-GWDM
Study First Received: August 17, 2009
Results First Received: September 5, 2013
Last Updated: June 6, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
Estonia: Ravimiamet, Estonian State Agency of Medicines
Korea: Korea Food and Drug Administration
Russia: Ministry of Health of Russian Federation
Argentina: ANMAT (Administración Nacional de Medicamentos, Alimentos, y Tecnología Médica)
Mexico: COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)