Background and Aims

Glycemic variability is a known risk factor for cardiovascular complications in type 2 diabetes mellitus (T2DM). Yoga is a moderate intensity physical activity and is considered to be beneficial for patients with T2DM. The objective of the current study is to understand the effect of yoga on glycemic variability.

Methods

Individuals with T2DM (n=60) of both genders, 40-70 years of age, HbA1C between 7% - 8.5% were recruited from a tertiary referral centre for diabetes. Subjects were randomly assigned to either intervention (yoga) or control (brisk walking) group. During the first 7 days, baseline glycemic variability was established using Freestyle Libre pro flash glucose monitoring system, followed by 7 days of either one hour of yoga or walking per day. A traditional validated yoga module was taught. Data on glycemic variability was obtained on baseline, day 7 and 14.

Results

In total, 57 participants successfully completed the study. Mean reduction in daily average glucose level was higher in intervention groups than control group (23.99±18.78 vs 8.69±27.08 mg/dL), with no significant difference between groups (p>0.05). However, significant reduction in various measures of glycemic variability was observed in intervention group (SD: 9.79 ±7.56 vs 4.67 ±7.13; MAGE: 17.47 ±21.25 vs 6.15 ±13.6; % CV: 3.33 ±4.09 vs1.03 ±2.98; MODD: 8.38 ±6.18 vs 1.16 ±8.08) when compared to the control group (p < 0.001).

Conclusions

Short term yoga practice has shown a statistically significant reduction in the glycemic variability in T2DM when compared to brisk walking, inspite of a similar reduction in mean blood glucose levels.

Background and Aims

URLi is a novel insulin lispro formulation that shows accelerated absorption and improved postprandial glucose control compared to lispro. We evaluated the compatibility and safety of URLi vs. lispro in patients with T1D currently using CSII. Primary endpoint was the rate of infusion set failures due to a pump occlusion alarm, or unexplained hyperglycemia with blood glucose >250 mg/dL (13.9 mmol/L) that did not decrease within 1 hour following a correction bolus delivered via the pump.

Methods

This Phase 3, double-blind, crossover study included 6 weeks of each treatment after a 2-week lead-in period on lispro. Forty-nine patients were randomized. Boluses were initiated 0-2 minutes prior to meals. Patients were required to

- Change infusion sets every 72 ± 4 hours

- Record infusion set changes and reason

- Use Dexcom G5 (real-time mode)

Results

There was no significant difference in the incidence and rate of infusion set failures between URLi and Lispro (primary endpoint). URLi showed a statistically significantly higher overall premature infusion set change rate, but difference was small, translating to 1 additional infusion set change every 2-3 months.

A higher incidence of treatment-emergent adverse events (TEAEs) was observed for URLi, driven by infusion site reaction and pain, which was mostly reported by one investigative site. Over 90% of these were mild severity. Incidence of all other TEAEs was low and similar between groups.

Conclusions

URLi was compatible with CSII use with a safety profile similar to lispro. URLi demonstrated a trend towards improved glycemic control in patients with T1D.

Background and Aims

SAR341402 (SAR-Asp) was developed as a biosimilar/follow-on to rapid-acting insulin NovoLog^_®/NovoRapid^® (NN-Asp). Efficacy and safety results, including immunogenicity, for SAR-Asp and NN-Asp in patients with type 1 diabetes (T1DM) or type 2 diabetes (T2DM) are similar. Further subgroups analyses were done by baseline factors (age, ethnicity, race, BMI, duration of diabetes and HbA_1c).

Methods

GEMELLI-1 (NCT03211858) was a 6-month (with 6-month extension) open-label randomised phase 3 study of SAR-Asp and NN-Asp in people with T1DM or T2DM using insulin glargine 100 U/mL (Gla-100) as basal insulin. Primary endpoint was HbA_1c change (non-inferiority margin of 0.3 %) from baseline to Week 26.

Results

597 participants were randomized, with similar baseline characteristics in both treatment groups. The mean change in HbA_1c at Week 26 was similar in both treatment groups in the total cohort as well as in subgroup analyses based on baseline BMI (≥30 vs <30 kg/m²), duration of diabetes (≥10 or <10 years), eGFR (≥60 vs <60 mL/min/1.73 m²), and ethnicity (Table). In these subgroups, the incidence of hypoglycaemia, especially severe hypoglycaemia (SAR-Asp 4.0%; NN-Asp 3.4%), was similar in participants who received SAR-Asp and NN-Asp. The immunogenicity data and TEAEs in subgroups were also consistent with the overall population (Table).

Conclusions

SAR341402 was as effective and well tolerated as insulin aspart in people with T1DM or T2DM regardless of the baseline characteristics.

Background and Aims

This exploratory subgroup analysis of the PIONEER programme evaluated the effect of baseline HbA_1c on overall HbA_1c and bodyweight reductions achieved during each trial.

Methods

Data from patients who participated in PIONEER 1–5, 7 and 8 (n=5657) were grouped by trial and according to baseline HbA_1c (≤8.0%, >8.0–≤9.0% and >9.0%). In the PIONEER trials, patients received either once daily treatment with oral semaglutide (3, 7 or 14 mg, or flexibly dosed) or a comparator (placebo, empagliflozin 25 mg, sitagliptin 100 mg or liraglutide 1.8 mg). Endpoints were change from baseline in HbA_1c and bodyweight at week 26 (week 52 in PIONEER 7).

Results

Reductions from baseline in HbA_1c and bodyweight were greater with increasing oral semaglutide dose. HbA_1c reductions were also greater with higher baseline HbA_1c, but there was no consistent relationship between change in bodyweight and baseline HbA_1c. Reductions in HbA_1c were greater with oral semaglutide 7 mg and 14 mg versus placebo and versus active comparator in all subgroups (Table). Significant interactions by baseline HbA_1c were observed for oral semaglutide vs comparator in PIONEER 3 (14 mg), PIONEER 4 (14 mg vs placebo), and PIONEER 8 (7 and 14 mg).

Conclusions

Oral semaglutide showed improved glycaemic control across baseline HbA_1c subgroups in the PIONEER trials, with greater reductions in HbA_1c with oral semaglutide 7 and 14 mg versus all comparators in all subgroups. Reductions in HbA_1c were greater with higher oral semaglutide dose and higher baseline HbA_1c.