Dataset Information

A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes.

ABSTRACT:

Background

The efficacy/safety of device-supported versus routine titration with Gla-300 in type 2 diabetes (T2DM) was evaluated.

Method

AUTOMATIX was a 16-week, randomized, open-label, parallel-group, multicenter, noninferiority trial in insulin-treated or insulin-naïve people with T2DM. The fasting self-monitored plasma glucose (FSMPG) target was 90-130 mg/dL (5.0-7.2 mmol/L). Primary endpoint: proportion of participants achieving target FSMPG at week 16 without severe hypoglycemia. Secondary endpoints included: proportion reaching FSMPG target without confirmed (?70 mg/dL [?3.9 mmol/L]) or severe hypoglycemia; time to first achieve FSMPG target; mean FSMPG and HbA1c change (baseline to week 16). Safety endpoints included hypoglycemia and adverse events. Patient-reported outcomes (PROs) were also assessed.

Results

Participants were randomized to device-supported (n = 75) or routine titration (n = 76); 17 participants in the device-supported group discontinued device use. Noninferiority was achieved for the primary endpoint (device-supported: 45.9%, routine: 36.8%; weighted difference: 9.04 [95% CI: -6.75, 24.83]), but not superiority (P = .262). The proportion reaching FSMPG target range without confirmed (?70 mg/dL [?3.9 mmol/L]) or severe hypoglycemia was 34.3% vs 14.5%, respectively. The time at which 50% of the participants achieved the FSMPG target was less in the device-supported than routine titration arm (10 vs 13 weeks). Least squares mean HbA1c reduction, safety profiles, and PROs were similar in both arms. Mean "ease of use" score for the device, assessed by healthcare professionals and participants on a scale of 1-7, was ?6.

Conclusions

Device-supported self-titration had a good safety/efficacy profile, and was noninferior to routine titration and well accepted by diabetes specialists and patients.

SUBMITTER: Davies M

PROVIDER: S-EPMC6955447 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes.

Davies Melanie M Bain Steve S Charpentier Guillaume G Flacke Frank F Goyeau Harmonie H Woloschak Michael M Hasslacher Christoph C Vespasiani Giacomo G Edelman Steven S

Journal of diabetes science and technology 20190115 5

<h4>Background</h4>The efficacy/safety of device-supported versus routine titration with Gla-300 in type 2 diabetes (T2DM) was evaluated.<h4>Method</h4>AUTOMATIX was a 16-week, randomized, open-label, parallel-group, multicenter, noninferiority trial in insulin-treated or insulin-naïve people with T2DM. The fasting self-monitored plasma glucose (FSMPG) target was 90-130 mg/dL (5.0-7.2 mmol/L). Primary endpoint: proportion of participants achieving target FSMPG at week 16 without severe hypoglyce ...[more]

PMID: 30646755

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Project description:IntroductionThis study assessed the efficacy and safety of insulin glargine 300 U/mL (Gla-300) during hospitalization and therapy intensification at discharge in insufficiently controlled people with type 2 diabetes.Research design and methodsCOBALTA (for its acronym in Spanish, COntrol Basal durante la hospitalizacion y al ALTA) was a multicenter, open-label, single-arm, phase IV trial including 112 evaluable inpatients with type 2 diabetes insufficiently controlled (glycosylated hemoglobin (HbA1c) 8%-10%) with basal insulin and/or non-insulin antidiabetic drugs. Patients were treated with a basal-bolus-correction insulin regimen with Gla-300 during the hospitalization and with Gla-300 and/or non-insulin antidiabetics for 6 months after discharge. The primary endpoint was the HbA1c change from baseline to month 6 postdischarge.ResultsHbA1c levels decreased from 8.8%±0.6% at baseline to 7.2%±1.1% at month 6 postdischarge (p<0.001, mean change 1.6%±1.1%). All 7-point blood glucose levels decreased from baseline to 24 hours predischarge (p≤0.001, mean changes from 25.1±66.6 to 63.0±85.4 mg/dL). Fasting plasma glucose also decreased from baseline to 24 hours predischarge (p<0.001), month 3 (p<0.001) and month 6 (p<0.001) postdischarge (mean changes 51.5±90.9, 68.2±96.0 and 77.6±86.4 mg/dL, respectively). Satisfaction was high and hyperglycemia/hypoglycemia perception was low according to the Diabetes Treatment Satisfaction Questionnaire at month 6 postdischarge. The incidence of confirmed (glucose<70 mg/dL)/severe hypoglycemia was 25.0% during hospitalization and 59.1% 6 months after discharge. No safety concerns were reported.ConclusionsInpatient and intensification therapy at discharge with Gla-300 improved significantly glycemic control of patients with type 2 diabetes insufficiently controlled with other basal insulin and/or non-insulin antidiabetic medication, with high treatment satisfaction. Gla-300 could therefore be a treatment choice for hospital and postdischarge diabetes management.

Dataset Information

A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes.

Background

Method

Results

Conclusions

Publications

A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes.

Similar Datasets

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