From the Guidelines
The initial treatment for type 2 diabetes mellitus (T2DM) should be metformin, if not contraindicated and if tolerated, as it is the preferred initial pharmacological agent. This recommendation is based on the strongest and most recent evidence from the 2018 consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) 1.
Key Considerations
- Metformin is effective in decreasing hepatic glucose production and improving peripheral insulin sensitivity, making it a suitable first-line treatment for most patients with T2DM.
- The medication has a low risk of hypoglycemia and is weight-neutral or promotes modest weight loss, which are important considerations for patients with T2DM.
- Lifestyle modifications, including dietary changes and regular physical activity, should be initiated alongside metformin therapy to achieve optimal glycemic control.
Treatment Approach
- Patients should start with dietary changes focusing on reduced calorie intake, portion control, and limiting refined carbohydrates while increasing fiber intake.
- Regular physical activity of at least 150 minutes per week of moderate-intensity exercise is recommended.
- Metformin should be started at a dose of 500 mg once or twice daily with meals, gradually increasing to a target dose of 1000-2000 mg daily divided into two doses to minimize gastrointestinal side effects.
- Blood glucose monitoring should be initiated, with target fasting glucose of 80-130 mg/dL and post-meal glucose below 180 mg/dL.
- If metformin alone is insufficient after 3 months of therapy, or if initial HbA1c is above 9%, additional medications may be needed, as suggested by the 2016 American Diabetes Association standards of medical care in diabetes 1.
Rationale
- The preference for metformin as the initial pharmacological agent is based on its efficacy, safety, tolerability, low cost, and extensive clinical experience, as highlighted in the 2018 consensus report 1.
- The medication has been shown to have benefits on clinical outcomes related to diabetes, with less hypoglycemia and weight gain than with insulin or sulfonylureas, as demonstrated in a substudy of the UKPDS 1.
From the FDA Drug Label
three randomized, double-blind, placebo-controlled trials with durations from 16 to 26 weeks were conducted to evaluate the use of ACTOS as monotherapy in patients with type 2 diabetes.
The initial treatment for type 2 diabetes mellitus (T2DM) is not explicitly stated in the provided drug labels as the primary or initial treatment option. The studies described in the labels focus on the use of pioglitazone (ACTOS) as monotherapy or in combination with other antidiabetic agents in patients with type 2 diabetes.
- Monotherapy: The labels describe the efficacy of pioglitazone as monotherapy in improving glycemic control in patients with type 2 diabetes.
- Combination Therapy: They also discuss the use of pioglitazone in combination with sulfonylurea, metformin, or insulin in patients who were inadequately controlled on these therapies alone.
However, the labels do not provide information on the initial treatment approach for type 2 diabetes mellitus. Therefore, based on the provided information, the FDA drug label does not answer the question.
From the Research
Initial Treatment for Type 2 Diabetes Mellitus (T2DM)
The initial treatment for T2DM typically involves a combination of lifestyle modifications and medication. Some key points to consider include:
- Lifestyle intervention, which encompasses a healthful eating plan, physical activity, and often medication, is part of the initial treatment as well as the ongoing management of type 2 diabetes 2
- Metformin is recommended as the first-line antidiabetic medication, as it attenuates insulin resistance, a key pathogenesis of T2DM 3
- Dipeptidyl peptidase-4 (DPP-4) inhibitors, such as sitagliptin, can be used as an add-on therapy to metformin, or as an initial combination therapy, to provide excellent efficacy and safety in patients with T2DM 4, 3
Medication Options
Some medication options for the initial treatment of T2DM include:
- Metformin, which is recommended as the first-line antidiabetic medication 3
- DPP-4 inhibitors, such as sitagliptin, which can be used as an add-on therapy to metformin, or as an initial combination therapy 4, 3
- Thiazolidinediones, such as pioglitazone, which can be used in combination with sitagliptin or metformin to provide additive efficacy in reducing blood glucose 5
- Glucagon-like peptide-1 receptor agonists, which can be used in combination with metformin to provide weight loss potential and target multiple pathophysiologic defects in patients with T2DM 6
Lifestyle Modifications
Lifestyle modifications are an essential part of the initial treatment and ongoing management of T2DM. Some key lifestyle modifications include: