Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDegLira · 2 trials · 2 indications
Drug-free diabetes remission is defined as HbA1C \< 6.5 % off glucose-lowering agents for at least 12 weeks.
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise |
| Standard Care | NO_INTERVENTION | Standard glycemic care as informed by the current clinical practice guidelines |
| IDegLira | EXPERIMENTAL | Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks. |
| Basal-Bolus Insulin | ACTIVE_COMPARATOR | Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart. |
| Name | Type | Description |
|---|---|---|
| IDegLira | DRUG | Dose is titrated to achieve fasting normoglycemia |
| insulin degludec | DRUG | In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia. |
| Metformin | DRUG | Dose is titrated to 2000 mg per day or maximal tolerated dose |
| Lifestyle Therapy | BEHAVIORAL | Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving |
| Insulin Degludec (U-100) | DRUG | Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose. |
| Insulin Aspart | DRUG | Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL. |
Inclusion Criteria: 1. men and women aged 30-80 years; 2. T2D diagnosed within 5 years 3. stable T2D drug regimen in the 8 weeks before randomization; 4. HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose lowering drugs; 5. body mass index ≥ 23 kg/m2; 6. ability and willin...
IDegLira is an investigational drug being studied for the treatment of Type 2 Diabetes Mellitus. It is a combination therapy developed by Novo Nordisk A/S (NVO) and is currently in Phase 3 clinical development for this indication.
IDegLira is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus.
IDegLira is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Type 2 Diabetes Mellitus, and clinical trials are ongoing to assess its effects.
IDegLira has been evaluated in two completed Phase 3 clinical trials. The first trial, NCT03737240, known as the IDegLira HIGH Trial, enrolled 145 participants in the United States. The second trial, NCT03862716, focused on remission evaluation of a metabolic intervention for Type 2 Diabetes with IDegLira, enrolled 159 participants in Canada.
IDegLira is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of Type 2 Diabetes Mellitus. The drug has not yet received regulatory approval, and its safety and efficacy are still being evaluated in clinical trials.