TY - JOUR
T1 - Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise)
T2 - A randomised open-label controlled trial
AU - Reznik, Yves
AU - Cohen, Ohad
AU - Aronson, Ronnie
AU - Conget, Ignacio
AU - Runzis, Sarah
AU - Castaneda, Javier
AU - Lee, Scott W.
N1 - Funding Information:
The study was sponsored by Medtronic International Trading Sàrl, Tolochenaz, Switzerland. We thank the OpT2mise study team at Medtronic for their support; and the monitors, investigators, study coordinators, and patients for having done this trial. We also thank Simona de Portu, John Shin, and Severine Liabat (employees of Medtronic), for their assistance throughout the conduct of the study. Medical writing and editorial assistance in the preparation of this paper, funded by Medtronic, was provided by Dr Michael Shaw (MScript, Hove, UK).
PY - 2014
Y1 - 2014
N2 - Background Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results. We aimed to resolve this uncertainty with a randomised controlled trial (OpT2mise). Methods We did this multicentre, controlled trial at 36 hospitals, tertiary care centres, and referal centres in Canada, Europe, Israel, South Africa, and the USA. Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period. After the run-in period, patients with glycated haemoglobin of 8 0-12 0% (64-108 mmol/mol) were randomly assigned (1:1) by a computer-generated randomisation sequence (block size 2 with probability 0 75 and size 4 with probability 0 25) to pump treatment or to continue with multiple daily injections. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01182493. Findings 495 of 590 screened patients entered the run-in phase and 331 were randomised (168 to pump treatment, 163 to multiple daily injections). Mean glycated haemoglobin at baseline was 9% (75 mmol/mol) in both groups. At 6 months, mean glycated haemoglobin had decreased by 1 1% (SD 1 2; 12 mmol/mol, SD 13) in the pump treatment group and 0 4% (SD 1 1; 4 mmol/mol, SD 12) in the multiple daily injection group, resulting in a between-group treatment difference of -0 7% (95% CI -0 9 to -0 4; -8 mmol/mol, 95% CI -10 to -4, p<0 0001). At the end of the study, the mean total daily insulin dose was 97 units (SD 56) with pump treatment versus 122 units (SD 68) for multiple daily injections (p<0 0001), with no significant difference in bodyweight change between the two groups (1 5 kg [SD 3 5] vs 1 1 kg [3 6], p=0 322). Two diabetes-related serious adverse events (hyperglycaemia or ketosis without acidosis) resulting in hospital admission occurred in the pump treatment group compared with one in the multiple daily injection group. No ketoacidosis occurred in either group and one episode of severe hypoglycaemia occurred in the multiple daily injection group. Interpretation In patients with poorly controlled type 2 diabetes despite using multiple daily injections of insulin, pump treatment can be considered as a safe and valuable treatment option.
AB - Background Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results. We aimed to resolve this uncertainty with a randomised controlled trial (OpT2mise). Methods We did this multicentre, controlled trial at 36 hospitals, tertiary care centres, and referal centres in Canada, Europe, Israel, South Africa, and the USA. Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period. After the run-in period, patients with glycated haemoglobin of 8 0-12 0% (64-108 mmol/mol) were randomly assigned (1:1) by a computer-generated randomisation sequence (block size 2 with probability 0 75 and size 4 with probability 0 25) to pump treatment or to continue with multiple daily injections. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01182493. Findings 495 of 590 screened patients entered the run-in phase and 331 were randomised (168 to pump treatment, 163 to multiple daily injections). Mean glycated haemoglobin at baseline was 9% (75 mmol/mol) in both groups. At 6 months, mean glycated haemoglobin had decreased by 1 1% (SD 1 2; 12 mmol/mol, SD 13) in the pump treatment group and 0 4% (SD 1 1; 4 mmol/mol, SD 12) in the multiple daily injection group, resulting in a between-group treatment difference of -0 7% (95% CI -0 9 to -0 4; -8 mmol/mol, 95% CI -10 to -4, p<0 0001). At the end of the study, the mean total daily insulin dose was 97 units (SD 56) with pump treatment versus 122 units (SD 68) for multiple daily injections (p<0 0001), with no significant difference in bodyweight change between the two groups (1 5 kg [SD 3 5] vs 1 1 kg [3 6], p=0 322). Two diabetes-related serious adverse events (hyperglycaemia or ketosis without acidosis) resulting in hospital admission occurred in the pump treatment group compared with one in the multiple daily injection group. No ketoacidosis occurred in either group and one episode of severe hypoglycaemia occurred in the multiple daily injection group. Interpretation In patients with poorly controlled type 2 diabetes despite using multiple daily injections of insulin, pump treatment can be considered as a safe and valuable treatment option.
UR - http://www.scopus.com/inward/record.url?scp=84923582829&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(14)61037-0
DO - 10.1016/S0140-6736(14)61037-0
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C2 - 24998009
AN - SCOPUS:84923582829
SN - 0140-6736
VL - 384
SP - 1265
EP - 1272
JO - The Lancet
JF - The Lancet
IS - 9950
ER -