FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

In continuation of my update on dapagliflozin, and metformin hydrochloride

 

Dapagliflozin            Saxagliptin                                   and  (Metformin)

The US Food and Drug Administration (FDA) has approved Qternmet XR(dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).

The approval is based on two Phase III trials, which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D.

In one trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%. In the second trial, treatment with 10mg dapagliflozin/5mg saxagliptin in addition to metformin extended release demonstrated statistically-significant decreases in HbA1c, and an increase in the number of patients achieving an HbA1c <7%.

The safety results of the individual medicines in these trials were consistent with their known profile.

About Qternmet XR

Qternmet XR is a once-daily, oral medicine compromised of the selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor dapagliflozin, the dipeptidyl peptidase‑4 (DPP‑4) inhibitor saxagliptin and metformin hydrochloride extended release. Qternmet XR is approved in the US as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.

https://en.wikipedia.org/wiki/Dapagliflozin

https://en.wikipedia.org/wiki/Saxagliptin

https://www.drugbank.ca/drugs/DB06335

https://www.drugbank.ca/drugs/DB00331

https://en.wikipedia.org/wiki/Metformin

FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

In continuation of my update on dapagliflozin

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity™ 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza® 0.9 mg after 52 weeks of treatment. Eli Lilly and Company (NYSE: LLY) will present these data at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston.

"These data not only reinforce once-weekly Trulicity as a safe and efficacious GLP-1 receptor agonist, but further support the value for Japanese patients, with greater A1C reductions compared to once-daily Victoza," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "We are pleased to present these study findings, which capture important information about a key region where type 2 diabetes is on the rise."

The study's primary objective was met, with Trulicity 0.75 mg demonstrating a greater A1C reduction from baseline compared to placebo at 26 weeks. At the final endpoint of 52 weeks, which is the focus of the data presentation at the meeting, Trulicity 0.75 mg demonstrated statistically greater A1C reductions compared to Victoza 0.9 mg, the highest approved dose in Japan (-1.39 percent vs. -1.19 percent). Additional results showed:

Trulicity 0.75 mg provided statistically greater reductions in the average self-monitored blood glucose levels compared to Victoza 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and

Trulicity 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to Victoza 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity™ 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza® 0.9 mg after 52 weeks of treatment. Eli Lilly and Company (NYSE: LLY) will present these data at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston.

"These data not only reinforce once-weekly Trulicity as a safe and efficacious GLP-1 receptor agonist, but further support the value for Japanese patients, with greater A1C reductions compared to once-daily Victoza," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "We are pleased to present these study findings, which capture important information about a key region where type 2 diabetes is on the rise."

The study's primary objective was met, with Trulicity 0.75 mg demonstrating a greater A1C reduction from baseline compared to placebo at 26 weeks. At the final endpoint of 52 weeks, which is the focus of the data presentation at the meeting, Trulicity 0.75 mg demonstrated statistically greater A1C reductions compared to Victoza 0.9 mg, the highest approved dose in Japan (-1.39 percent vs. -1.19 percent). Additional results showed:

Trulicity 0.75 mg provided statistically greater reductions in the average self-monitored blood glucose levels compared to Victoza 0.9 mg (-53.1 mg/dL vs. -46.8 mg/dL); and Trulicity 0.75 mg significantly lowered average post-meal blood glucose levels from baseline compared to Victoza 0.9 mg (-63.7 mg/dL vs. -55.4 mg/dL).

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Farxiga Approved for Type 2 Diabetes - Drugs.com MedNews

In continuation of my update on Farxiga

Farxiga (dapagliflozin) has been approved by the U.S. Food and Drug Administration to treat adults with type 2 diabetes, the agency said Wednesday in a news release.

The drug, to be used for blood sugar control along with proper diet and exercise, is designed to prevent re-absorption of glucose by the kidneys. Type 2 diabetes affects some 24 million people, accounting for 90 percent of diabetes cases in the United States, the FDA said.

Farxiga Approved for Type 2 Diabetes - Drugs.com MedNews

AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S

In continuation of my update on Dapagliflozin

AstraZeneca and Bristol-Myers Squibb resubmit Dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes

Dapagliflozin more effective than sitagliptin for adult patients with type 2 diabetes: 

In continuation of my update on dapagliflozin and sitagliptin

The study also demonstrated significant reductions in total body weight and fasting plasma glucose (FPG) levels in patients taking dapagliflozin added to sitagliptin (with or without metformin), with results maintained throughout the duration of the study extension.

Patients were actively questioned at each study visit for signs, symptoms or events suggestive of genital infections and urinary tract infections. These events were more frequent with the dapagliflozin treatment group compared to the placebo treatment group, and were generally mild to moderate in intensity, with most patients responding to standard treatment.

"Type 2 diabetes is a complex disease that often requires patients to take multiple treatments to control their blood sugar levels, with DPP4 inhibitors being some of the most widely prescribed therapies," said Serge Jabbour, M.D., Division Director of Endocrinology, Thomas Jefferson University. "In this study, dapagliflozin, in addition to diet and exercise, resulted in reduced blood sugar levels when added to sitagliptin, a DPP4 inhibitor. These findings add to our understanding of the effect of dapagliflozin in combination with commonly prescribed type 2 diabetes treatments."

Bristol-Myers Squibb Company and AstraZeneca today announced results from a Phase 3 clinical study that showed the investigational compound dapagliflozin 10 mg demonstrated significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with type 2 diabetes.

More..

New and effective diabetes drug seeking approval

We know that, Dapagliflozin is an experimental drug being studied by Bristol-Myers Squibb in partnership with AstraZeneca as a potential treatment for type 1 and 2 diabetes. Although dapagliflozin's method of action would operate on either type of diabetes or other conditions resulting in hyperglycemia, the current clinical trials specifically exclude participants with Type 1 diabetes.Dapagliflozin inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2), which is responsible for at least 90% of the glucosereabsorption in the kidney. Blocking this transporter causes blood glucose to be eliminated through the urine.
New and effective diabetes drug seeking approval

Combination of Depagliflozin & Metaformin for type 2 diabatic ?

We knew that these two Depagliflozin (left) & Metaformin (right) compounds were being studied independently for type 2 diabetic condition. Dapagliflozin, an investigational compound, is a potential first-in-class SGLT2 inhibitor currently in Phase 3 trials under joint development as a once-daily oral therapy for the treatment of type 2 diabetes. SGLT2 inhibitors facilitate the elimination of glucose by the kidney, thereby returning serum glucose levels towards normal.

A recent study (24-week phase 3 clinical study by Bristol-Myers Squibb Company and AstraZeneca) demonstrated that the investigational drug dapagliflozin, added to metformin, demonstrated significant mean reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c) and in the secondary endpoint, fasting plasma glucose (FPG) in patients with type 2 diabetes inadequately controlled with metformin alone, as compared to placebo plus metformin. Dapagliflozin is a novel, selective, sodium glucose co-transporter 2 (SGLT2) inhibitor.

The study also showed that individuals receiving dapagliflozin had statistically greater mean reductions in body weight compared to individuals taking placebo. Results from the 24-week study were presented at the 45th European Association for the Study of Diabetes Annual Meeting. This is the first public presentation of dapagliflozin Phase 3 data.

More interestingly, data on weight loss and blood pressure may be important adjuvants to glycemic control and is of great importance and hope in the days to come the SGLT2 inhibitors ( improved glycemic control) will play an important role in the type 2 diabetes. Given the continued rising prevalence of type 2 diabetes, there is an urgent need to have drugs of this kind..

Ref : http://www.astrazeneca.com/media/latest-press-releases/Dapagliflozen_Study014_EASD?itemId=7108139