Clinical trial NCT01217892: Evaluation of Dapagliflozin Taken Twice-daily
Official title: A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
metformin treated
inadequate control
metformin treatment alone
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-10-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Diagnosis of T2DM
* Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
* HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
* History of diabetic ketoacidosis
* Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
* FPG \>270 mg/dL (\>15.0 mmol/L)
* BMI \>45 kg/m2

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Adjusted Percent Change in Body Weight
timeFrame: Baseline to Week 16
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
timeFrame: Baseline to Week 1
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
timeFrame: Baseline to Week 16
measure: Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Asslar
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Biberach A.d. Riss
country: Germany
facility: Research Site
city: Bosenheim
country: Germany
facility: Research Site
city: Dippoldiswalde
country: Germany
facility: Research Site
city: Falkensee
country: Germany
facility: Research Site
city: Meissen
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Neuwied
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Wahlstedt
country: Germany
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Csongrad
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyongyos
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: TAT
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Namestovo
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
city: Prievidza
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Ruzomberok
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Verulam
country: South Africa
facility: Research Site
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Umkomaas
country: South Africa
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
state: Graubunden
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: Kreuzlingen
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Rorschach
country: Switzerland
facility: Research Site
city: Dnipropetrov'sk
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vynnitsa
country: Ukraine
facility: Research Site
city: Zaporozhye
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Shamik Parikh
role: STUDY_DIRECTOR
References:
citation: Schumm-Draeger PM, Burgess L, Koranyi L, Hruba V, Hamer-Maansson JE, de Bruin TW. Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial. Diabetes Obes Metab. 2015 Jan;17(1):42-51. doi: 10.1111/dom.12387. Epub 2014 Oct 16.