Clinical trial NCT01006590: Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
Official title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Saxagliptin
Randomised
Double-blind
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-11-03
Enrollment: 286
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 evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent
* Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
* HbA1c ≥7.0% and ≤10.0%

Exclusion Criteria:

* Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
* Renal impairment as defined by a creatinine clearance \<60 mL/min/1.73 m2
* Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study

Primary outcomes:
measure: Absolute Change From Baseline in HbA1c at Week 24
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
timeFrame: 24 Weeks
measure: Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
timeFrame: 24 Weeks
measure: Change From Baseline to Week 24 in Fasting Plasma Glucose
timeFrame: Baseline and 24 weeks
measure: Change From Baseline to Week 24 in Fasting Insulin
timeFrame: Baseline and 24 weeks
measure: Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Research Site
city: Brussels (woluwe-st-lambert)
country: Belgium
facility: Research Site
city: Halen
country: Belgium
facility: Research Site
city: Lommel
country: Belgium
facility: Research Site
city: Moerkerke
country: Belgium
facility: Research Site
city: Oostham
country: Belgium
facility: Research Site
city: Sint-gillis-waas
country: Belgium
facility: Research Site
city: Tielt
country: Belgium
facility: Research Site
city: Zoersel
country: Belgium
facility: Research Site
city: Chatellerault
country: France
facility: Research Site
city: Corbeil Essonnes
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Seysses
country: France
facility: Research Site
city: Tierce
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Rhaunen
country: Germany
facility: Research Site
city: Schmiedeberg
country: Germany
facility: Research Site
city: Wahlstedt
country: Germany
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Forli
country: Italy
facility: Research Site
state: FC
city: Milano
country: Italy
facility: Research Site
state: MI
city: Padova
country: Italy
facility: Research Site
state: PD
city: Pordenone
country: Italy
facility: Research Site
state: PN
city: Siena
country: Italy
facility: Research Site
state: SI
city: Roma
country: Italy
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucia
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Research Site
state: Galicia
city: Ankara
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Kirikkale
country: Turkey
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
state: Berks
city: Atherstone
country: United Kingdom
facility: Research Site
state: Warwickshire
city: Leamington Spa
country: United Kingdom
facility: Research Site
state: Warwks
city: Warminster
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Westbury
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Ashford
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: Hermans MP, Delibasi T, Farmer I, Lohm L, Maheux P, Piatti P, Malvolti E, Jorgens S, Charbonnel B. Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study. Curr Med Res Opin. 2012 Oct;28(10):1635-45. doi: 10.1185/03007995.2012.735646. Epub 2012 Oct 12.