Investigation of a switch from Insulin Therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus

• Register: EUCTR
• Last refreshed on: 3 June 2013
• Main ID: EUCTR2009-016745-25-DE
• Date of registration: 16/11/2009
• Prospective Registration: Yes
• Primary sponsor: ikfe GmbH
• Public title: Investigation of a switch from Insulin Therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus
• Scientific title: Investigation of a switch from Insulin Therapy to a metformin & saxagliptin combination in patients with type 2 diabetes mellitus
• Date of first enrolment: 20/01/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016745-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
- Combination of OAD and basal insulin treatment (BOT) or intensified conventional therapy (ICT; > 2 injections of basal and prandial) or conventional insulin therapy (CIT; 1 or 2 injections of basal or biphasic)
- HbA1c < 7.5 %
- Age: 18-80 years inclusively
- Duration of insulin therapy > 1 year
- Insulin dose < 120 IU/day
- Fasting C-peptide > 0.6 ng/l
- Fasting glucose = 210 mg/dl
- Full legal, mental and physical ability to give informed consent
- Patient consent that the general physician will be informed of trial participation
- Experience ion self measurement of blood glucose <1 year

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:
- Type 1 Diabetes mellitus
- History of drug or alcohol abuse within the last five years prior to screening
- History of severe or multiple allergies
- Progressive fatal disease
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), neurological, psychiatric and/or haematological disease as judged by the investigator
- renal insufficiency or history of significant renal diseases (creatinine clearance lower than 60ml/min determined using the Cockroft-Goult equation)
- Contra-indications for study drugs including contraindications for the rescue drugs
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- Pregnancy or breast feeding
- Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
- Treatment with any other investigational drug within 3 months prior to screening
- Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study


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

Health Condition(s) or Problem(s) studied

Type 2 Diabetes mellitus
MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

Trade Name: OnglyzaTM
Product Name: Saxagliptin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SAXAGLIPTIN
CAS Number: 361442-04-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Metformin Sandoz®
Product Name: Metformin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Actos 30 mg tablets
Product Name: Pioglitazone
Pharmaceutical Form: Tablet
CAS Number: 112529-15-4
Other descriptive name: PIOGLITAZONE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Trade Name: Lantus
Product Name: Lantus
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337951
Concentration unit: U/ml unit(s)/millilitre

Trade Name: Metformin Sandoz®
Product Name: Metformin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Pharmaceutical Form:
CAS Number: 08/10/9004
Other descriptive name: INSULIN

Pharmaceutical Form:

Primary Outcome(s)

Secondary Objective: The secondary objectives are the impact of the switch on biomarkers of insulin resistance and ß-cell function, biomarkers of cardiovascular risk, patient treatment satisfaction, treatment costs, and requirement of 3rd line pioglitazone as rescue drug as well as on an oral glucose tolerance test (oGTT). Further the impact of the switch on the macrophage activation is a secondary objective in a subgroup at the site 01.

Main Objective: The primary objective of the study is to show the effect of a switch from insulin therapy (BOT or ICT or CIT) to an oral therapy with saxagliptin & metformin over a period of six months in comparison to continuation of insulin therapy. Primary endpoint is the percentage of patients with stable HbA1c (no increase: delta < 0.5%) after switch.

Primary end point(s): Primary endpoint is the percentage of patients with stable HbA1c after switch from insulin therapy (BOT or ICT or CIT) to an oral therapy with metformin & saxagliptin.

Secondary ID(s)

AZ-SAX-001