Clinical trial NCT00960661: 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
Official title: A Randomized 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 Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
Byetta
insulin lispro
Humalog
insulin glargine
Lantus
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-08-18
Enrollment: 1036
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.


Eligibility criteria: Inclusion Criteria:

* Have been taking a basal insulin Glargine, at dose of ≥ 20 units/day, for at least 3 months prior to study start.
* Have been taking basal insulin Glargine at dose of ≥ 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:

  * Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
  * Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
* Have an HbA1C \> 7.0% and ≤ 10.0%.
* Have a body mass index (BMI) between ≥ 25 and ≤ 45 kg/m2.

Exclusion Criteria:

* Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
* Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
* Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have previously completed or been withdrawn from this study after enrollment.

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
timeFrame: Baseline, 30 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1C < 7.0%
timeFrame: Week 30
measure: Percent of Participants Achieving HbA1c ≤ 6.5%.
timeFrame: Week 30
measure: Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
timeFrame: Baseline, Week 30
measure: Change in Total Cholesterol From Baseline to Week 30
timeFrame: Baseline, week 30
measure: Change in High Density Lipoprotein (HDL) From Baseline to Week 30
timeFrame: Baseline, week 30
measure: Change in Low Density Lipoprotein (LDL) From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Change in Body Weight From Baseline to Week 30.
timeFrame: baseline, week 30
measure: Change in Systolic Blood Pressure (SBP) From Baseline to Week 30
timeFrame: Baseline, Week 30
measure: Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30
timeFrame: baseline, Week 30
measure: Daily Insulin Glargine Dose at Baseline and at Week 30
timeFrame: Baseline, week 30
measure: Major Hypoglycemia Rate Per Year
timeFrame: 30 weeks
measure: Minor Hypoglycemia Rate Per Year
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Corrientes
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Rafael
country: Argentina
facility: Research Site
city: Arlon
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Merksem
country: Belgium
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Vantaa
country: Finland
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Auxerre
country: France
facility: Research Site
city: Bar Le Duc
country: France
facility: Research Site
city: Douai Cedex
country: France
facility: Research Site
city: La Roche Sur Yon
country: France
facility: Research Site
city: La Rochelle Cedex 1
country: France
facility: Research Site
city: Le Creuzot
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Marseille Cedex 20
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Nanterre
country: France
facility: Research Site
city: Pessac Cedex
country: France
facility: Research Site
city: Rennes Cedex 2
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse Cedex 9
country: France
facility: Research Site
city: Venissieux
country: France
facility: Research Site
city: Bad Lauterberg
country: Germany
facility: Research Site
city: Dippoldiswalde
country: Germany
facility: Research Site
city: Friedrichsthal
country: Germany
facility: Research Site
city: Goch
country: Germany
facility: Research Site
city: Grevenbroich
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Saarbruecken
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Olbia
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Ulsan-Si
country: Korea, Republic of
facility: Research Site
city: Wonju-Si
country: Korea, Republic of
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Cuernavaca
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Almere
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Beek
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Hoogeveen
country: Netherlands
facility: Research Site
city: Sittard-Geleen
country: Netherlands
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisbon
country: Portugal
facility: Research Site
city: Portugal
country: Portugal
facility: Research Site
city: Hato Rey
country: Puerto Rico
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Dos Hermanas
country: Spain
facility: Research Site
city: La Coruna
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Halmstad
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Penarth
country: United Kingdom
facility: Research Site
city: Wakefield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.