A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational Period

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004951-12-LV
• Date of registration: 05/11/2007
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational Period
• Scientific title: A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational Period
• Date of first enrolment: 05/02/2008
• Target sample size: 168
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004951-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
At visit 1:
Provision of informed consent
Diagnosed with type 2 diabetes
Men or women who are equal to or above 18 years of age
Documented history of CrCl less than 50 ml/min within 3 last months
WOCBP using an adequate method of contraception
At visit 2:
HbA1c above or equal to 7.0% and less than or equal to 11.0%
C-peptide level above or equal to 0.375nmol/L, 1.0ng/mL
Estimated CrCl less than 50 ml/min
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
At visit 1:
Pregnancy or breastfeeding
Initiation of insulin therapy within 4 weeks of study entry
Allowed oral antidiabetic therapy that has not been stable within the last 4 weeks
Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic
Treatment with metformin within 4 weeks prior to visit 1
Treatment with thiazolidinedione within 12 weeks prior to visit 1
Systemic treatment with oral prednisolone above 10 mg per day
Treatment with CYP450 3A4 inducers, HIV or antiviral drugs
Contraindications to therapy as outlined in the saxagliptin IB
Congestive heart failure (NYHA) class III or IV and/or left ventricular ejection fraction equal to or less than 40%
Significant cardiovascular history within the past 6 months
Type I diabetes, history of diabetic ketoacidosis or hypomolar non-ketonic coma
History of 2 or more major hypoglycemic events the last 3 months, haemoglobinopathies, alcohol or illegal drug abuse
Donation of blood, plasma or platelets within the last 3 months
Involvement in planning or conduct of the study
Participating in a clinical study within 90 days
Unable to complete the study, protocol or medication non-compliant
At visit 2:
Active liver disease and/or significant abnormal liver function
Creatinine kinase above or equal to 3xULN
History of positive serologic evidence of current infectious liver disease
Anemia
Clinically significant abnormality














Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus

Intervention(s)

Product Name: Saxagliptin 2.5 mg
Product Code: BMS-477118-11
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: saxagliptin
CAS Number: 361442-04-8
Current Sponsor code: BMS-477118-11
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The first 12 weeks of treatment will be used for the primary assessment of treatment effect and tolerability, after which the following 40 weeks will be used to assess the long-term efficacy, safety and tolerability.

The primary variable is absolute change from baseline in HbA1c level at week 12.

Secondary Objective:

Main Objective: Short-term:
To evaluate the efficacy of saxagliptin 2.5 mg in adult patients with type 2 diabetes and renal impairment (moderate, severe and end-stage) compared with placebo by assessment of the absolute change from baseline in HbA1c and fasting plasma glucose
To evaluate the safety and tolerability of saxagliptin 2.5 mg compared with placebo by assessment of AEs, laboratory values, ECG, vital signs, body weight and physical examination
To characterize the PK properties of saxagliptin

Long-term:
To evaluate the safety and tolerability of sagliptin 2.5 mg compared with placebo by assessment of AEs, laboratory values, ECG, vital signs, body weight and physical examiniation
To evaluate the efficacy of oral treatment with saxagliptin 2.5 mg compared with placebo by assessment of the absolute change from baseline in HbA1c and fasting plasma glucose
To assess the change from baseline in background anti-diabetic therapy

Secondary ID(s)

D1680C00007