A 6-month, Multicenter, single-Arm, observational study with a 6-month extension evaluating patient-reported outcomes of insulin Glargine 300 U/mL (Gla-300) in
basal/bolus-treated people with T2 diabetes on therapy in a rEal world setting (MAGE study) (PRO of Insulin Glargine 300 U/mL in T2 diabetes in)

Study identification

• EU PAS number:
  EUPAS17150
• Study ID:
  45649
• Official title and acronym:
  A 6-month, Multicenter, single-Arm, observational study with a 6-month extension evaluating patient-reported outcomes of insulin Glargine 300 U/mL (Gla-300) in basal/bolus-treated people with T2 diabetes on therapy in a rEal world setting (MAGE study) (PRO of Insulin Glargine 300 U/mL in T2 diabetes in)
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  This is a 6-months, multicenter, prospective, single-arm observational Belgian study with Gla-300 with a 6-months extension.The study is non-interventional on the therapeutic strategy.Patients serve as their own control.The inclusion procedure and documentation of data will not affect daily prescription routines, and the ADA/EASD position statement regarding treatment of type 2 diabetes will be respected.Patients fulfilling the study criteria will be asked to participate to this study. They will be asked to sign written consent after the study being explained and before any study related procedure. They will be in the study for at least 6 months, after which they will be proposed to continue in the extension study for another 6 months. If a patient discontinues, then the reason for it will be documented.After the baseline visit, it is expected that 2 visits with a possibility of 2 extra visits if a patient agrees to the extension study, will be scheduled by the physician. Measurements will therefore be taken at 3 and 6 months (the main study) and at 9 and 12 months (the extension study).Additional contacts if deemed necessary by the investigator or as in current practice are allowed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Prof. Dr. C. Mathieu UZ Gasthuisberg Leuven, Dr. P. Kleynen CHU St Pierre Brussels, Dr. Fabienne Liénart CHU Tivoli La Louvière, Dr. E. Heyns AZ Groeninge Kortrijk, Dr. A. Verhaegen AZ Jan Palfijn Merksem, Dr. L. Derdelinckx Clinique Saint-Luc Bouge, Prof. I. Colin CHR Mons-Hainaut – Site St-Joseph Mons, Dr. P. Abrams GZA ziekenhuizen Wilrijk, Dr. V. Preumont CU St Luc - Brussels, Dr Ramon (A Paré) + Dr Liénart (St Jean) CHU A. Paré (Mons) + St Jean (Brussels)

Study timelines

Date when funding contract was signed

Actual:19/04/2016

Study start date

Actual:31/05/2016

Date of final study report

Planned:29/03/2019

Actual:03/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Belgium

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Study Number and Name: GLARGL07973 - MAGEBelgian Nr.: B707201628266