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ADA 2014 – GLP-1 Update

For this month’s special feature we have a selection of the GLP-1 abstracts and releases from the recent American Diabetes Association’s 74th Scientific Sessions in San Francisco.

New one-year data of IDegLira shows glucose-lowering effect was maintained for people with type 2 diabetes

New Phase 3a findings show IDegLira, the investigational once-daily single injection combination of insulin degludec and liraglutide, for the treatment of people with type 2 diabetes, maintained its glucose-lowering effect and confirmed safety evaluations for up to one year.

The DUAL™ I extension trial compared the efficacy and safety of IDegLira with insulin degludec and liraglutide 1.8 mg alone in insulin-naïve adults with type 2 diabetes uncontrolled on metformin with or without pioglitazone. At 52 weeks, IDegLira demonstrated a statistically significant and sustained HbA1c (blood glucose) reduction of 1.8% from baseline versus 1.4% for insulin degludec and 1.2% for liraglutide (p<0.0001). The average HbA1c at the end of the trial was 6.4% for IDegLira, 6.9% with insulin degludec and 7.1% with liraglutide…..

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New phase 3 study shows efficacy and safety of Victoza® (liraglutide [rDNA origin] injection) for the treatment of type 2 diabetes in adults with moderate renal impairment

Data from a new phase 3 study demonstrated that once-daily Victoza® (liraglutide [rDNA origin] injection) provided greater glycemic control versus placebo with no worsening of renal function in adults with type 2 diabetes and moderate renal impairment. The data were presented at the 74th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA.

Renal impairment is one of the more challenging and common long-term complications of diabetes and limits the use of available antidiabetic treatment options.

The 26-week, double-blind, randomized, controlled study investigated the efficacy and safety of Victoza® compared with placebo when added to preexisting oral antidiabetic treatment, insulin or a combination thereof. The study showed that adults with type 2 diabetes and moderate renal impairment, defined as those with stage 3 chronic kidney disease (eGFR 30-59 mL/min/1.73 m2; MDRD), treated with Victoza® had significantly greater improvements in mean HbA1c (a measure of blood glucose levels) (-1.05% vs. -0.38%; ETD -0.66% [95% CI: -0.90;-0.43]; p<0.0001), were more likely to achieve target HbA1c <7% (52.8% vs. 19.5%; p<0.0001), and experienced significantly greater weight loss from baseline (-2.41 kg/5.31 lbs vs. -1.09 kg/2.40 lbs; ETD -1.32 kg/2.90 lbs [95% CI: -2.24;-0.40]; p=0.0052) versus placebo. No worsening of renal function and a lower incidence of hypoglycemia with treatment of Victoza® compared with placebo were observed in the study.

Results from the AWARD-2 trial,

Evaluated the safety and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated patients reached target HbA1c levels of less than 7 percent. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels.  Both doses of dulaglutide were associated with sustained weight loss, while insulin glargine showed weight gain.

Results from the AWARD-4 trial

The first Phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin – showed that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7 percent, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30 percent less total insulin dose.  Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with relative weight benefit compared to the basal/bolus therapy of insulin glargine and mealtime insulin lispro.

Hypoglycemia rates were lower in dulaglutide 1.5 mg-treated patients compared to insulin glargine in both studies. In AWARD-2, the 0.75 mg dose also had a lower rate of hypoglycemia compared to insulin glargine.

Adverse events were similar for dulaglutide-treated patients in both studies. The most frequently reported events were gastrointestinal-related, including nausea, diarrhea and vomiting. Nausea, which was mostly mild to moderate, was the most commonly reported event. These findings are consistent with prior studies of once-weekly dulaglutide.

Harmony 1, 2, 4 and 5

The latest studies evaluated the newly approved GLP-1 mimetic, albiglutide, in monotherapy as well as in combination with OADs, against placebo, insulin glargine and a thiazolidinedione (pioglitazone). 

Harmony 1 evaluated the efficacy and safety of albiglutide against placebo in patients inadequately controlled (HbA1c 7-10%) on pioglitazone ± metformin. All endpoints of success were met.

Harmony 2 examined the efficacy and safety of albiglutide at 30mg and 50mg versus placebo in patients inadequately controlled (HbA1c 7-10%) on diet and exercise. A1c lowering was inline with expected results.

Harmony 4 assessed the efficacy and safety of albiglutide 30mg once weekly versus insulin glargine in type 2 diabetes mellitus patients inadequately controlled (HbA1c 7-10%) on metformin ± sulfonylurea.and all data points were met and the use of albiglutide was non-inferior to insulin galrgine.

Harmony 5 evaluated the efficacy and safety of albiglutide versus placebo and versus pioglitazone in people inadequately controlled (HbA1C 7.0-10.0%) on background dual therapy of metformin and glimepiride and this part of the study pioglitazone was found to be superior.

ITCA 650 by Intarcia Therapeutics, Inc. 

The first 6-month data from an ongoing open-label phase 3 trial with in type 2 diabetes.  Patients in the trial had longstanding disease and significantly elevated HbA1C levels between 10%-12% despite treatment that included diet, exercise and antidiabetes medications. Nearly 70% of patients in the trial at baseline had very poor glucose control despite being treated with 1, 2 and even 3 oral diabetes therapies. The interim data showed marked improvements of HbA1C reductions ≥2% were achieved by 78% of subjects who completed at least 13 weeks of treatment; 50% achieved >3% and 22% achieved ≥4% reductions.

ITCA 650 (continuous subcutaneous delivery of exenatide). The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted sub-dermally and can deliver the GLP-1 mimetic exenatide 24/7 without a single shot.