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Study · Randomized controlled trial · n = 212 · 2007

5 results

Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin.

Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O

Diabetes care13 Aug 2007Cited by 78 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes using basal insulin, more pramlintide recipients achieved the composite diabetes control endpoint than placebo recipients.

    In plain wordsIn patients with type 2 diabetes using basal insulin, the combined diabetes control target was reached more often with pramlintide than placebo.

    Outcome
    IncreaseComposite diabetes control endpoint
    Study

    n = 212

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    60 or 120 microg b.i.d./t.i.d. · 16 weeksAs given in this study (human).

    Measurements

    Composite endpoint achievement
    25%
    pramlintide
    Composite endpoint achievement
    7%
    placebo

    Source sentences

    Summary
    More pramlintide- than placebo-treated patients achieved the composite end point (25 vs. 7%; P < 0.001).
    4 context sentences
    Summary · context
    The other coprimary end point was a composite measure of overall diabetes control comprising A1C or = 0.5%, mean daily postprandial glucose (PPG) increments < or = 40 mg/dl, no increase in body weight, and no severe hypoglycemia.
    Summary · context
    Patients meeting all four conditions at week 16 achieved this end point.
    Summary · context
    In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with or without oral antidiabetes agents (OAs) were randomized to addition of pramlintide (60 or 120 microg b.i.d./t.i.d.) or placebo.
    Summary · context
    Insulin glargine was adjusted to target a fasting plasma glucose concentration of 70-100 mg/dl.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes using basal insulin, A1C decreased more with pramlintide than placebo.

    In plain wordsIn patients with type 2 diabetes using basal insulin, A1C fell more with pramlintide than placebo.

    Outcome
    DecreaseA1C change
    Study

    n = 212

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    60 or 120 microg b.i.d./t.i.d. · 16 weeksAs given in this study (human).

    Measurements

    A1C change
    −0.7%
    pramlintide
    A1C change
    −0.36%
    placebo

    Source sentences

    Summary
    Reductions (means +/- SE) in A1C (-0.70 +/- 0.11% vs. -0.36 +/- 0.08%; P < 0.05) and PPG increments (-24.4 +/- 3.6 mg/dl vs. -0.4 +/- 3.0 mg/dl; P < 0.0001) were greater in pramlintide- versus placebo-treated patients, respectively.
    3 context sentences
    Summary · context
    One coprimary end point was the change in A1C at week 16.
    Summary · context
    In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with or without oral antidiabetes agents (OAs) were randomized to addition of pramlintide (60 or 120 microg b.i.d./t.i.d.) or placebo.
    Summary · context
    Insulin glargine was adjusted to target a fasting plasma glucose concentration of 70-100 mg/dl.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes using basal insulin, postprandial glucose increments decreased more with pramlintide than placebo.

    In plain wordsIn patients with type 2 diabetes using basal insulin, glucose rises after meals fell more with pramlintide than placebo.

    Outcome
    DecreasePostprandial glucose increments
    Study

    n = 212

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    60 or 120 microg b.i.d./t.i.d. · 16 weeksAs given in this study (human).

    Measurements

    PPG increment change
    −24.4 mg/dl
    pramlintide
    PPG increment change
    −0.4 mg/dl
    placebo

    Source sentences

    Summary
    Reductions (means +/- SE) in A1C (-0.70 +/- 0.11% vs. -0.36 +/- 0.08%; P < 0.05) and PPG increments (-24.4 +/- 3.6 mg/dl vs. -0.4 +/- 3.0 mg/dl; P < 0.0001) were greater in pramlintide- versus placebo-treated patients, respectively.
    2 context sentences
    Summary · context
    In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with or without oral antidiabetes agents (OAs) were randomized to addition of pramlintide (60 or 120 microg b.i.d./t.i.d.) or placebo.
    Summary · context
    Insulin glargine was adjusted to target a fasting plasma glucose concentration of 70-100 mg/dl.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes using basal insulin, weight fell with pramlintide but rose with placebo.

    In plain wordsIn patients with type 2 diabetes using basal insulin, weight fell with pramlintide but rose with placebo.

    Outcome
    DecreaseBody weight change
    Study

    n = 212

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    60 or 120 microg b.i.d./t.i.d. · 16 weeksAs given in this study (human).

    Measurements

    Weight change
    −1.6 kg
    pramlintide
    Weight change
    0.7 kg
    placebo

    Source sentences

    Summary
    Glycemic improvements were accompanied by progressive weight loss with pramlintide and weight gain with placebo (-1.6 +/- 0.3 kg vs. +0.7 +/- 0.3 kg; P < 0.0001).
    2 context sentences
    Summary · context
    In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with or without oral antidiabetes agents (OAs) were randomized to addition of pramlintide (60 or 120 microg b.i.d./t.i.d.) or placebo.
    Summary · context
    Insulin glargine was adjusted to target a fasting plasma glucose concentration of 70-100 mg/dl.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with type 2 diabetes using basal insulin, no treatment-related severe hypoglycemia occurred in the pramlintide study.

    In plain wordsIn patients with type 2 diabetes using basal insulin, the pramlintide study reported no treatment-related severe low-glucose events.

    Outcome
    Not applicableTreatment-related severe hypoglycemia
    Study

    n = 212

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    60 or 120 microg b.i.d./t.i.d. · 16 weeksAs given in this study (human).

    Source sentences

    Summary
    No treatment-related severe hypoglycemia occurred.
    2 context sentences
    Summary · context
    In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with or without oral antidiabetes agents (OAs) were randomized to addition of pramlintide (60 or 120 microg b.i.d./t.i.d.) or placebo.
    Summary · context
    Insulin glargine was adjusted to target a fasting plasma glucose concentration of 70-100 mg/dl.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT00240253

A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

AstraZenecan = 200Oct 2005 to Jun 2006

Type 2 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 31 Mar 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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